AccessGUDID - DEVICE: Nordic Chem A.M. 2.0 (00860009074521)

GUDID

Device Identifier (DI) Information

Brand Name: Nordic Chem A.M. 2.0
Version or Model: NCAM001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NCAM001
Company Name: Safe.R World Corporation

Primary DI Number: 00860009074521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048020664 *Terms of Use

Device Description: A next generation, water based long term antimicrobial coating. Designed to inhibit the growth of microorganisms for extended periods after application.

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:	No
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?
65345	Durable disinfectant coating	A substance (e.g., ready-to-use solution or solution additive) intended to be applied to a surface, noninvasive device, or clothing to create an enduring (long-life) coating with an antimicrobial and/or antiviral effect, that inactivates and destroys pathogens with a specific mechanism (e.g., photocatalytic oxidation, oligodynamic effect).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRJ	Disinfectant, Medical Devices

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
Special Storage Condition, Specify: Store in a dry, cool place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: daa5dd32-6e23-45d7-9613-6b97cb5b66f7
Public Version Date: September 01, 2022
Public Version Number: 1
DI Record Publish Date: August 24, 2022