DEVICE: Monosyn (04046964495892)
Device Identifier (DI) Information
Monosyn
C0023706
In Commercial Distribution
C0023706
B BRAUN SURGICAL SA
C0023706
In Commercial Distribution
C0023706
B BRAUN SURGICAL SA
MONOSYN UNDYED 5/0 (1) 45CM DGMP13
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 |
---|---|
Polyglyconate suture | A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from polyglyconate (prepared from a copolymer of glycolic acid and trimethylene carbonate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (especially in paediatric cardiovascular surgeries). It may include an attached needle intended to be disposed of after single use. The thread provides extended 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 |
---|
Device Size Text, specify: Size of Thread (USP - Others) : 5/0 |
Device Size Text, specify: Thread Material : glyconate |
Length: 45.00 Centimeter |
Device Record Status
b443d894-d9bc-44de-a692-093cd4bbb22f
June 27, 2018
3
November 12, 2015
June 27, 2018
3
November 12, 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:
04046964495885
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