TITAN™ DOUBLE WIRE

Basic Information

• Brand Name: TITAN™ DOUBLE WIRE
• Primary DI: 00853190008949
• Version / Model: 132.640.62
• Company Name: JACE MEDICAL, LLC
• Labeler DUNS: 063554875
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-10-10
• Public Version: 4
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 24a40cc6-db16-4e0d-b9d7-c543acafc45c
• Distribution End Date: 2022-12-31

Device Description

MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, BE2 NEEDLE, 65MM, USP 6, 14", 2 PK

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
PTX	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt	General, Plastic Surgery	878.4495	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	00853190008147	GS1	Carton	12	Not in Commercial Distribution	2022-12-31
Primary	00853190008949	GS1
Unit of Use	00853190008253	GS1

Customer Contacts

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