X-Gut™ Plain Gut Suture

Basic Information

• Brand Name: X-Gut™ Plain Gut Suture
• Primary DI: D765GP4019450
• Version / Model: GP401945
• Company Name: Osteogenics Biomedical Inc
• Labeler DUNS: 123853058
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-01
• Public Version: 1
• Public Version Date: 2025-09-09
• Public Version Status: New
• Public Device Record Key: d813b5d2-c1ce-4b92-b4cf-d3cf1b9829f8

Device Description

Plain Gut, USP 4-0, 19 mm 3/8 Circle Reverse Cutting Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	878.4830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45025	Catgut suture, chromic	A single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D765GP4019451	HIBCC	Box	12	In Commercial Distribution
Primary	D765GP4019450	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K072930	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			19 mm 3/8 Circle Reverse Cutting Needle
Device Size Text, specify			USP 4-0
Length	18	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius