DEVICE: OPTILENE (04046964796647)
Device Identifier (DI) Information
OPTILENE
G3095149
In Commercial Distribution
G3095149
B BRAUN SURGICAL SA
G3095149
In Commercial Distribution
G3095149
B BRAUN SURGICAL SA
OPTILENE 6/0(0,7)45CM 2XDRM10B 200CVRCP
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 |
---|---|
Polypropylene suture | A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polypropylene, an isostatic crystalline stereoisomer of a linear propylene polymer, 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; as the material does not adhere to tissues, it is typically used in cases where the suture is to be removed after healing. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAW | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
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: 45.0 Centimeter |
Device Size Text, specify: Thread Material : polypropylene with polyethylen |
Device Size Text, specify: Size of Thread (USP - Others) : 6/0 |
Device Record Status
34ca48d1-12df-44bf-b0dd-bf2bd3be793b
March 29, 2018
2
December 11, 2016
March 29, 2018
2
December 11, 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:
04046964796630
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