Covidien G1798K - SUTURE, CHROMIC, GUT, 4-0, 18, UD, SS-2, 12/BX

Covidien G1798K – SUTURE, CHROMIC, GUT, 4-0, 18, UD, SS-2, 12/BX

Covidien G1798K Chromic Gut Suture, Premium Spatula, 18″, Needle SS-2, 1/2 Circle, Size 4-0 (Pack of 12)

CHROMIC GUT sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of beef (bovine) intestines. They are packaged in a solution of 89% isopropanol, 10% water and 1% triethanolmaine. CHROMIC GUT is treated with chromic salt solution. Mild chromic sutures are specially treated for ophthalmic and cuticular applications.

The manufacture of catgut raw material, consisting of long ribbons of highly selected serosal tissue, ensures:

• Purity of collagen for optimal tensile strength and in-vivo performance
• Uniform treatment with a buffered chromium salt solution, resulting in a chromic strand with a more predictable strength and uniform in-vivo absorption
• Surface smoothness to facilitate knot run-down and knot strength, due to electronic polishing of each strand.

Chromic gut sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular or neurological surgery.

Premium Spatula – Chromic Gut Size 4-0, 1/2 Circle, 45cm, SS-2

Item No.	Suture Type	Absorption Rate	USP	Metric	Length	Qty
G1798K	Absorbable	Variable (14-28 days)	4-0	2	18″	12

Indications

Chromic gut sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular or neurological surgery.

Contraindications

The use of these sutures is contraindicated in patients with known sensitivities or allergies to collagen or chromium, as gut is a collagen based material and CHROMIC GUT is treated with chromic salt solutions.

Actions

CHROMIC GUT sutures elicit a minimal acute inflammatory reaction in tissues characteristic of foreign body response to a substance. This is followed by gradual loss of tensile strength and suture mass, as the enzymatic process dissolves the surgical gut until it is completely absorbed.

Tensile Strength

Many factors may affect the rate of tensile strength loss. These include:

• Type of suture
• Presence of infection
• Tissue sites

Absorption

Absorption of CHROMIC GUT sutures occurs by enzymatic process similar to the digestion of an animal protein by the body. Being enzymatic, the process is subject to different influencing factors (see above) and it is virtually impossible to indicate the exact designation of a consistent absorption time.

Packaging

CHROMIC GUT absorbable sutures are available in USP and EP sizes 2 (6 metric) through 7-0 (0.7 metric). The sutures are supplied sterile, in pre-cut lengths or ligating reels; non-needled or affixed to various needle types, using both permanent and removable needle attachment techniques; in one, two or three dozen boxes.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as “Not made with natural rubber latex”:	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No