ETHI-PAK

Basic Information

• Brand Name: ETHI-PAK
• Primary DI: 10705031036741
• Version / Model: DS24
• Catalog Number: DS24
• Company Name: ETHICON INC.
• Labeler DUNS: 002144145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 6
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 3fe47c18-5b69-443f-96ba-c78c9aedf3f3

Device Description

Stainless Steel, Nonabsorbable Surgical 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAQ	SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE	General, Plastic Surgery	878.4495	2
GAR	Suture, nonabsorbable, synthetic, polyamide	General, Plastic Surgery	878.5020	2
GAT	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE	General, Plastic Surgery	878.5000	2
GAP	SUTURE, NONABSORBABLE, SILK	General, Plastic Surgery	878.5030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15971	Metallic suture, monofilament	A single-strand (monofilament), non-bioabsorbable wire made of metal (e.g., surgical steel, titanium) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching (e.g., for abdominal wound closure, intestinal anastomosis, hernia repair), or transosseous (through bone) stitching (e.g., sternal closure); it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is used primarily in orthopaedic, neurosurgical, and thoracic applications and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it may be retained for permanent support. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031036748	GS1	BOX	12	In Commercial Distribution
Primary	10705031036741	GS1
Unit of Use	80705031036740	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K931271	000