AccessGUDID - DEVICE: ATRAMAT (07500142011221)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: PGA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PE2493-75B
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142011221
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 PGA SURGICAL SUTURE UNDYED USP 3-0 EP 2, 75 CM NEEDLE PE-24 PREMIUM REVERSE CUTTING 24 MM 3/8 CIRCLE PGA INCOLORO USP 3-0, 75 CM AGUJA PE-24 REVERSO CORTANTE PREMIUM 24 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13908	Polyglycolic acid suture	A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040282	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

[?]

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

[?]

Size Type Text
Length: 24 Millimeter
Device Size Text, specify: USP 3-0
Device Size Text, specify: 3/8 CIRCLE
Device Size Text, specify: SUTURE UNDYED
Device Size Text, specify: ATRAMAT PGA

Device Record Status

Public Device Record Key: ece2bf7b-1f7d-4a86-85c9-9c071b04f77e
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 28, 2016