TITAN™ DOUBLE WIRE

Basic Information

• Brand Name: TITAN™ DOUBLE WIRE
• Primary DI: 00853190008963
• Version / Model: 132.640.22
• 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: 3
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 52ec152f-30ac-4700-8f20-ee4e3e737d08
• Distribution End Date: 2022-12-31

Device Description

MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, BE3 NEEDLE, 49MM, 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
GAO	Suture, Nonabsorbable	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
Unit of Use	00853190008246	GS1
Primary	00853190008963	GS1
Package	00853190008680	GS1	Carton	12	Not in Commercial Distribution	2022-12-31

Customer Contacts

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