AccessGUDID - DEVICE: Zorflex (05060467570152)

GUDID

Device Identifier (DI) Information

Brand Name: Zorflex
Version or Model: ZF15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ZF15
Company Name: CHEMVIRON CARBON LIMITED

Primary DI Number: 05060467570152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 399080118 *Terms of Use

Device Description: Odor adsorbing medical wound dressing consisting of cut pieces of activated carbon cloth

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):	Yes
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?
47475	Odour-absorbent dressing, antimicrobial	A pad covering for malodourous wounds or lesions (e.g., venous leg ulcers, fungating carcinomas, infected surgical wounds), that absorbs the bad odours typically through a layer of activated charcoal, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. Given the types of wounds to which it is typically applied, the device may also contain a layer that absorbs heavy exudates, and one that minimizes adherence to the wound. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from direct sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Length: 25 Centimeter
Width: 15 Centimeter

Device Record Status

Public Device Record Key: ff2dce68-67de-4047-b64e-1bdb11a79df4
Public Version Date: September 09, 2021
Public Version Number: 1
DI Record Publish Date: September 01, 2021