DEVICE: DEKNATEL (04026704591626)
Device Identifier (DI) Information
DEKNATEL
IPN011387
In Commercial Distribution
D-7375K
TELEFLEX INCORPORATED
IPN011387
In Commercial Distribution
D-7375K
TELEFLEX INCORPORATED
DEK MX BL MF 6-0 T-10 2N 18"
Device Characteristics
MR Safe | |
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
13909 | Polyolefin/fluoropolymer suture, monofilament |
A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAW | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: none |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: DEKLENE® MAXX™ /Needle T-10, T-10 Size-6-0 |
Length: 45 Centimeter |
Device Record Status
f08e683d-a225-49a9-86bd-e325b982ec04
June 02, 2023
5
October 16, 2015
June 02, 2023
5
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 |
---|---|---|---|---|---|
24026704591620 | 1 | 04026704591626 | In Commercial Distribution | Sleeve | |
44026704591624 | 36 | 24026704591620 | In Commercial Distribution | Box |
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