AccessGUDID - DEVICE: DEKNATEL (14026704637727)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN029048
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E29-7171M4A
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704637727
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704422845

Device Description: STAINLESS MONOFILAMENT 5 HSCX60 1N 4X75 CENTIMETER

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
GAQ	Suture, nonabsorbable, steel, monofilament and multifilament, sterile

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: none

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: STERNOTOMY /Needle HSCX60 Size-5
Length: 75 Centimeter

Device Record Status

Public Device Record Key: 480d0124-f031-4432-9710-326500276c6e
Public Version Date: January 11, 2024
Public Version Number: 6
DI Record Publish Date: December 03, 2018