DEVICE: Monomax (04046963989316)
Device Identifier (DI) Information
Monomax
B9941120
Not in Commercial Distribution
B9941120
B BRAUN SURGICAL SA
B9941120
Not in Commercial Distribution
B9941120
B BRAUN SURGICAL SA
MONOMAX VLT 1(4)150CM HR65 USA LOOP(MDDP
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 |
---|---|
Polybutester suture | A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polybutester, a copolymer of polyglycol terephthalate and polytrimethylene terephthalate, 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. It is very elastic and has a low coefficient of friction, making it ideal for surface closure, and does not lose tensile strength or become absorbed. 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: 150.00 Centimeter |
Device Record Status
a7f4d831-bc22-4989-a95d-cda2d27012b3
March 29, 2018
2
November 01, 2015
March 29, 2018
2
November 01, 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:
04046963989309
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