DEVICE: Monoplus (04046963567408)
Device Identifier (DI) Information
Monoplus
C0024443
In Commercial Distribution
C0024443
B BRAUN SURGICAL SA
C0024443
In Commercial Distribution
C0024443
B BRAUN SURGICAL SA
MONOPLUS VIOLET 5/0 (1) 90CM 2XHR17 (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 |
---|---|
Polyester suture, bioabsorbable, monofilament | A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEW | SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE |
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: Thread Material : polydioxanone |
Device Size Text, specify: Size of Thread (USP - Others) : 5/0 |
Device Record Status
f5138d53-3965-4c91-a70e-8b8128bd5d21
February 07, 2019
6
August 11, 2015
February 07, 2019
6
August 11, 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:
04046963567293
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