AccessGUDID - DEVICE: Premicron (04046963572785)

GUDID

Device Identifier (DI) Information

Brand Name: Premicron
Version or Model: M0027013
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M0027013
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046963572785
Issuing Agency: GS1
Commercial Distribution End Date: August 31, 2015
Device Count: 6
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: PREMICRONG/W2/0(3)4X75CM2XDRC18BCVPS6MLP

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: e4f489f5-d42d-49ab-bc8d-ad9bed47e9f6
Public Version Date: June 27, 2018
Public Version Number: 3
DI Record Publish Date: August 26, 2015