DEVICE: Zorflex (05060467570138)
Device Identifier (DI) Information
Zorflex
ZF10
In Commercial Distribution
ZF10
CHEMVIRON CARBON LIMITED
ZF10
In Commercial Distribution
ZF10
CHEMVIRON CARBON LIMITED
Odor adsorbing medical dressing consisting of cut pieces of activated carbon cloth
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
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: 10 Centimeter |
Width: 10 Centimeter |
Device Record Status
f262fa4e-bb59-46d2-91bd-1cd4d7ecd4a4
September 09, 2021
1
September 01, 2021
September 09, 2021
1
September 01, 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 |
---|---|---|---|---|---|
05060467570008 | 10 | 05060467570138 | In Commercial Distribution | Carton | |
05060467570091 | 10 | 05060467570008 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441915846962
customerservice-ccd.ccc@kuraray.com
customerservice-ccd.ccc@kuraray.com