DEVICE: NA (ESOT036980)
Device Identifier (DI) Information
NA
Surgical suture nonabsorbable monofil Lancet Point flat
Not in Commercial Distribution
03698
S & T AG
Surgical suture nonabsorbable monofil Lancet Point flat
Not in Commercial Distribution
03698
S & T AG
15 M 43 10-0 Lancet Point, flat 10-0, Nylon black, 30 cm, sterile Box with 12 sutures
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
38000 | Nylon suture, non-bioabsorbable, monofilament |
A single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. 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 |
---|---|
GAR | Suture, Nonabsorbable, Synthetic, Polyamide |
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: Do not use if package is damaged |
Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Special Storage Condition, Specify: Do not re-sterilise |
Special Storage Condition, Specify: Protect from moisture |
Special Storage Condition, Specify: Protect from direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 30 Centimeter |
Device Size Text, specify: USP 10-0 |
Device Record Status
ed48a48f-02f5-4c41-b7d8-20d48168e493
February 05, 2021
5
September 24, 2016
February 05, 2021
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
ESOT036981 | 12 | ESOT036980 | 2020-03-10 | Not in Commercial Distribution |
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
[?]
+41526727407
info@s-and-t.net
info@s-and-t.net