AccessGUDID - DEVICE: ATRAMAT (07500142053016)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: PDX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PE1974
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142053016
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2040
Device Count: 1
Labeler D-U-N-S® Number*: 811313428 *Terms of Use

Device Description: ATRAMAT PDX SURGICAL SUTURE VIOLET USP 4-0 EP 1,5, 70 CM NEEDLE PE-19 PREMIUM REVERSE CUTTING 19 MM 3/8 CIRCLE POLIDIOXANONA VIOLETA USP 4-0, 70 CM AGUJA PE-19 REVERSO CORTANTE PREMIUM 19 MM 3/8 CIRCULO

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polydioxanone suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] 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 extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Polydioxanone suture

A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of polydioxanone (PDS) [made from poly (p-dioxanone)] 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 extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
NEW	Suture, Surgical, Absorbable, Polydioxanone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041048	000

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

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Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 70 CM
Device Size Text, specify: USP 4-0 EP 1,5,
Device Size Text, specify: ATRAMAT PDX
Device Size Text, specify: SUTURE VIOLET
Device Size Text, specify: 3/8 CIRCLE
Device Size Text, specify: PE-19 PREMIUM REVERSE CUTTING
Length: 19 Millimeter

Device Record Status

Public Device Record Key: 86754305-a9ce-421e-91ae-7c54c64a9f2f
Public Version Date: July 06, 2018
Public Version Number: 5
DI Record Publish Date: October 17, 2016