DEVICE: Absorbest Super Foam (07350031913972)
Device Identifier (DI) Information
Absorbest Super Foam
F60046/10
In Commercial Distribution
F60046/10
Absorbest AB
F60046/10
In Commercial Distribution
F60046/10
Absorbest AB
Superabsorbent dressing
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| 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? |
|---|---|---|---|---|
| 43186 | Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial |
A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.
|
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 5 and 30 Degrees Celsius |
| Storage Environment Humidity: between 0 and 60 Percent (%) Relative Humidity |
| Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Length: 20 Centimeter |
| Width: 20 Centimeter |
Device Record Status
d70f2278-fb81-454e-b173-436a2693b0ae
July 22, 2024
1
July 12, 2024
July 22, 2024
1
July 12, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
17350031913979
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined