DEVICE: MONOMAX (04046963489991)
Device Identifier (DI) Information
MONOMAX
B0041077
In Commercial Distribution
B0041077
B BRAUN SURGICAL SA
B0041077
In Commercial Distribution
B0041077
B BRAUN SURGICAL SA
MONOMAX VIOLET 1(4)150CM HR40S LOOP(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 |
---|---|
Polyhydroxybutyrate suture | A sterile, single-strand (monofilament), synthetic, bioabsorbable thread derived from poly-4-hydroxybutyrate [a material isolated from prokaryotic cells using recombinant deoxyribonucleic acid (DNA) technology] 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 |
---|---|
NWJ | Suture, recombinant technology |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Thread Material : polyhydroxibutyrate |
Device Size Text, specify: Size of Thread (USP - Others) : 1 |
Length: 150.0 Centimeter |
Device Record Status
b96e6949-c727-4de4-b447-908155d0a039
March 29, 2018
2
November 25, 2016
March 29, 2018
2
November 25, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046963489984
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