Surgilon

Basic Information

• Brand Name: Surgilon
• Primary DI: 10884521072503
• Version / Model: 88861948-51
• Catalog Number: 88861948-51
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-31
• Public Version: 6
• Public Version Date: 2023-01-12
• Public Version Status: Update
• Public Device Record Key: 0083a64e-a200-4144-8350-f13d6415145c
• Distribution End Date: 2015-08-31

Device Description

Braided Nylon

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
GAR	SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE	General, Plastic Surgery	878.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37997	Nylon suture, non-bioabsorbable, multifilament	A multiple-strand (multifilament), 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 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
Package	20884521072500	GS1	CASE	36	Not in Commercial Distribution	2015-08-31
Primary	10884521072503	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981582	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			diameter,2/0,N/A;
Length	30	Inch