DEVICE: DEKNATEL (04026704428632)
Device Identifier (DI) Information
DEKNATEL
IPN027364
In Commercial Distribution
XS-915W
TELEFLEX INCORPORATED
IPN027364
In Commercial Distribution
XS-915W
TELEFLEX INCORPORATED
RC SLK WH BR 0 18"X12
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? |
---|---|---|---|---|
13910 | Silk suture |
A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAP | SUTURE, NONABSORBABLE, SILK |
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 |
---|
Length: 45 Centimeter |
Device Size Text, specify: SILK /Needle Size-0 |
Device Record Status
305b6cab-8331-420d-8d8d-445b933c423c
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 |
---|---|---|---|---|---|
44026704428630 | 36 | 24026704428636 | In Commercial Distribution | Box | |
24026704428636 | 1 | 04026704428632 | 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