AccessGUDID - DEVICE: ATRAMAT (07500142080463)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: PGLA90
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HP16306-45B
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142080463
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 PGLA90 SURGICAL SUTURE UNDYED USP 6-0 EP 0.7, 45 CM NEEDLE HP-16 ATRAGLIDE CUTTING 16 MM 1/2 CIRCLE PGLA90 INCOLORO USP 6-0, 45 CM AGUJA HP-16 CORTANTE ATRAGLIDE 16 MM 1/2 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":	Yes
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?
45814	Poliglecaprone suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) 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, 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 [?]
K072863	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: 16 Millimeter
Device Size Text, specify: 1/2 CIRCLE
Device Size Text, specify: SUTURE UNDYED
Device Size Text, specify: ATRAMAT PGLA90
Device Size Text, specify: USP 6-0

Device Record Status

Public Device Record Key: 5d036762-6a67-49ee-8d27-8dda67153728
Public Version Date: August 30, 2018
Public Version Number: 1
DI Record Publish Date: July 30, 2018