AccessGUDID - DEVICE: ATRAMAT (07500142005343)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: CHROMIC GUT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CE1216/2
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142005343
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 CHROMIC GUT SURGICAL SUTURE USP 6-0 EP 1, 45 CM DOUBLE NEEDLE CE-12 REVERSE CUTTING 12 MM 3/8 CIRCLE

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?
45025	Catgut suture, chromic	A single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAL	Suture, Absorbable, Natural

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K911354	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 Humidity: between 0 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 12 Millimeter
Device Size Text, specify: USP 6-0 EP 1

Device Record Status

Public Device Record Key: 220bf779-8916-4cfb-a361-a0f8e378094a
Public Version Date: March 16, 2021
Public Version Number: 1
DI Record Publish Date: March 08, 2021