DEVICE: BONDEK (04026704603916)
Device Identifier (DI) Information
BONDEK
IPN000863
In Commercial Distribution
833-136
TELEFLEX INCORPORATED
IPN000863
In Commercial Distribution
833-136
TELEFLEX INCORPORATED
Bondek Green Braided-Coated Size 2-0 36" CST-43 Needle T Needle BSC
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
13908 | Polyglycolic acid suture |
A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID |
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: store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Suture Length 36", Needle 1 Length 1.030", Needle 2 Length 0.156" |
Device Record Status
c9df407f-e104-480f-83bb-842f2be0e2fe
January 15, 2019
3
October 16, 2015
January 15, 2019
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 |
---|---|---|---|---|---|
24026704603910 | 12 | 04026704603916 | 2019-01-15 | Not 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