Quala Suture Silk

Basic Information

• Brand Name: Quala Suture Silk
• Primary DI: D023P0006509
• Version / Model: P00065
• Catalog Number: P00065
• Company Name: NATIONAL DISTRIBUTION & CONTRACTING, INC.
• Labeler DUNS: 009831413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: bdafec51-bcee-4005-951b-375fcef86db3

Device Description

Sterile suture gut plain 3/0 18 C31 absorbable suture

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: No
• 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
13898	Catgut suture, plain	A single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) 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	D023P000651	HIBCC		12
Primary	D023P0006509	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K896554	000