AccessGUDID - DEVICE: Curaplex (00818834020206)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 49-RED-ISO-912
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 49-RED-ISO-912
Company Name: TRI-ANIM HEALTH SERVICES, INC.

Primary DI Number: 00818834020206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010712461 *Terms of Use

Device Description: RED ISOLATION BAG 9 X12

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?
14426	Contaminated waste container	A container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of contaminated and/or otherwise hazardous biological materials (e.g., waste products containing or having been in contact with human blood, sputum, urine and/or faeces). It is not intended to exclusively contain sharps or for in vitro diagnostic purposes. It is typically used with a disposable liner and has a self-closing lid. It is typically identified with a contaminated material symbol on its labelling. The contents will be sent to disposal usually by incineration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNI	CONTAINER, SPECIMEN, NON-STERILE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: af5b96dc-d1ac-4253-94c2-c324e09043ed
Public Version Date: August 18, 2023
Public Version Number: 3
DI Record Publish Date: July 10, 2017