DEVICE: DEKNATEL (04026704426782)
Device Identifier (DI) Information
DEKNATEL
IPN026892
In Commercial Distribution
X-4616
TELEFLEX INCORPORATED
IPN026892
In Commercial Distribution
X-4616
TELEFLEX INCORPORATED
PLED SOFT 3/4"X3/8"X1/16" X4
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 90 Centimeter |
Device Size Text, specify: Soft Pledget /Needle 3/4" x 3/8" x 1/16" |
Device Record Status
98664e1c-3f5d-47cf-a46b-6fed596fccd1
February 05, 2021
3
October 16, 2015
February 05, 2021
3
October 16, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
44026704426780 | 36 | 24026704426786 | In Commercial Distribution | Box | |
24026704426786 | 1 | 04026704426782 | In Commercial Distribution | Sleeve |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(919)544-8000
CS@TELEFLEX.COM
CS@TELEFLEX.COM