DEVICE: Novosyn (04046963563103)
Device Identifier (DI) Information
Novosyn
G0068497
In Commercial Distribution
G0068497
B BRAUN SURGICAL SA
G0068497
In Commercial Distribution
G0068497
B BRAUN SURGICAL SA
NOVOSYN VIOLET 1 (4) 90CM HS37 (M)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Polyglactin suture | A sterile, multiple-strand (multifilament), synthetic, bioabsorbable thread made of polyglactin, typically coated (e.g., with a copolymer of lactide and glycolide, and calcium stearate), 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. 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. |
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 90.00 Centimeter |
Device Size Text, specify: Size of Thread (USP - Others) : 1 |
Device Size Text, specify: Thread Material : PGLA (90/10) |
Device Record Status
edaf5c8b-a3f9-4514-bd98-db77b67ecbc1
March 29, 2018
2
August 19, 2015
March 29, 2018
2
August 19, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046963542863
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com