MANI Sutures Nylon

Basic Information

• Brand Name: MANI Sutures Nylon
• Primary DI: 04546951500108
• Version / Model: 19
• Catalog Number: 19
• Company Name: MANI, INC.
• Labeler DUNS: 690622428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-25
• Public Version: 8
• Public Version Date: 2021-10-18
• Public Version Status: Update
• Public Device Record Key: 5a82e558-0cf0-4055-bffb-5bba43412183

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	878.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38000	Nylon suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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	04546951500108	GS1