AccessGUDID - DEVICE: TITAN™ DOUBLE WIRE (00853190008987)

GUDID

Device Identifier (DI) Information

Brand Name: TITAN™ DOUBLE WIRE
Version or Model: 132.641.22
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: JACE MEDICAL, LLC

Primary DI Number: 00853190008987
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 2
Labeler D-U-N-S® Number*: 063554875 *Terms of Use

Device Description: MONOFILAMENT 316 LVM STAINLESS STEEL SUTURE, CCS1 NEEDLE, 49MM, USP 6, 14", 2 PK

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PTX	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d42437c7-ac99-4ecb-913a-26236285500c
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 10, 2021