AccessGUDID - DEVICE: DEKNATEL (14026704646767)

GUDID

Device Identifier (DI) Information

Brand Name: DEKNATEL
Version or Model: IPN049570
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L-705
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704646767
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704423859

Device Description: PLEDGET SOFT LARGE 3/8X3/16X1/16

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
DXZ	PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

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
Device Size Text, specify: Soft Pledget /Needle 3/8" x 3/16" x 1/16"
Length: 90 Centimeter

Device Record Status

Public Device Record Key: 61b254d8-0691-4051-a351-c6929ed8e4de
Public Version Date: January 11, 2024
Public Version Number: 5
DI Record Publish Date: November 20, 2019