AccessGUDID - DEVICE: DEKNATEL (14026704724960)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN055475
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E13-6354
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704724960
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704637475

Device Description: POLYLENE GREEN 2-0 DS30 1N 75 CENTIMETER

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
31744	Cardiovascular patch, synthetic	An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAT	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

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
Length: 75 Centimeter
Device Size Text, specify: POLYLENE /Needle DS30 Size-2-0

Device Record Status

Public Device Record Key: b3ad7ce0-2f4e-4e91-8ae5-6a60196577f0
Public Version Date: January 11, 2024
Public Version Number: 2
DI Record Publish Date: June 11, 2021