STRATAFIX

Basic Information

• Brand Name: STRATAFIX
• Primary DI: 10705031465213
• Version / Model: SXPP2B433
• Catalog Number: SXPP2B433
• Company Name: ETHICON, LLC
• Labeler DUNS: 829465157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 1
• Public Version Date: 2023-08-14
• Public Version Status: New
• Public Device Record Key: 2ef97b91-1f8d-41ab-8d29-49733fa96f6d

Device Description

Stratafix (Spiral PDS Plus), Bidirectional

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• 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
NEW	Suture, surgical, absorbable, polydioxanone	General, Plastic Surgery	878.4840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64234	Barbed polyester suture, antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester, and containing an agent to locally inhibit bacterial growth, intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is absorbed by hydrolysis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031465210	GS1	BOX	12	In Commercial Distribution
Primary	10705031465213	GS1

Customer Contacts

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