DEVICE: Premicron (04046963572785)
Device Identifier (DI) Information
Premicron
M0027013
Not in Commercial Distribution
M0027013
B BRAUN SURGICAL SA
M0027013
Not in Commercial Distribution
M0027013
B BRAUN SURGICAL SA
PREMICRONG/W2/0(3)4X75CM2XDRC18BCVPS6MLP
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 | A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyester (a polymer of polyethylene terephthalate) fibres, that may be coated (e.g., with polybutilate/silicone), intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may also include an attached disposable needle or preloaded pledget for enhanced support. It is commonly used for vessel anastomosis and the placement of prosthetic materials, and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it elicits minimal tissue reaction and lasts indefinitely in the body. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE |
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: Thread Material : polyester |
Length: 75.00 Centimeter |
Device Size Text, specify: Size of Thread (USP - Others) : 2/0 |
Device Record Status
e4f489f5-d42d-49ab-bc8d-ad9bed47e9f6
March 29, 2018
2
August 26, 2015
March 29, 2018
2
August 26, 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:
04046963572778
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