ALIMED MONOFILAMENT DISPOSABLE 5.07 ADA LOPS 20/PK

Basic Information

• Brand Name: ALIMED MONOFILAMENT DISPOSABLE 5.07 ADA LOPS 20/PK
• Primary DI: 00733657225112
• Version / Model: 32745
• Catalog Number: 2970001018
• Company Name: ALIMED, INC.
• Labeler DUNS: 056007248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 4
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: e3b553f7-1a7a-4271-931a-6bc74ea22558

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBX	CATHETER, IRRIGATION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13909	Polyolefin/fluoropolymer suture, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) 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. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00733657225112	GS1
Unit of Use	00733657299090	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]