AccessGUDID - DEVICE: ATRAMAT (07500142000706)

GUDID

Device Identifier (DI) Information

Brand Name: ATRAMAT
Version or Model: CHROMIC GUT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G3713-75
Company Name: Internacional Farmacéutica, S.A. de C.V.

Primary DI Number: 07500142000706
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: No description.

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?
45045	Rigid optical intracranial/spinal endoscope, single-use	An endoscope with a rigid distal portion intended for the visual examination and treatment of the brain (e.g., ventricles, hydrocephalus) and/or spine and contents [e.g., vertebrae, intervertebral discs, spinal cord (myeloscopy)]; it is not dedicated for use in the epidural space (i.e., not a dedicated epiduroscope). Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle; it does not include video imaging capability, however, might be used with a separate video camera for optional video image viewing. This is a single-use device.	Active	false

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: 37 Millimeter
Device Size Text, specify: USP 3-0 EP 3

Device Record Status

Public Device Record Key: 0ee42b56-621f-425d-bf92-b13bfc584d4c
Public Version Date: November 03, 2023
Public Version Number: 2
DI Record Publish Date: March 08, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
07500142100703	12	07500142000706	2040-12-31	In Commercial Distribution	DOZEN
07500142200700	24	07500142000706	2040-12-31	In Commercial Distribution	BOX WITH 24 PACKS