DEVICE: Premilene (04046963697235)
Device Identifier (DI) Information
Premilene
X2090030
In Commercial Distribution
X2090030
B BRAUN SURGICAL SA
X2090030
In Commercial Distribution
X2090030
B BRAUN SURGICAL SA
PREMILENE 3/0 (2) 75CM HR22 CV RCP
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 |
---|
Device Size Text, specify: Size of Thread (USP - Others) : 3/0 |
Length: 75.00 Centimeter |
Device Size Text, specify: Thread Material : polypropylene |
Device Record Status
af9bcf37-3c5d-46b3-8569-1dd3c31e0085
March 29, 2018
2
August 30, 2015
March 29, 2018
2
August 30, 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:
04046963629717
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