DEVICE: DryMax SOFT (07350031913224)
Device Identifier (DI) Information
DryMax SOFT
F60121/10
In Commercial Distribution
F60121/10
Absorbest AB
F60121/10
In Commercial Distribution
F60121/10
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 |
| Special Storage Condition, Specify: Avoid direct sunlight |
| Storage Environment Humidity: between 20 and 60 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Length: 15 Centimeter |
| Width: 15 Centimeter |
Device Record Status
b67d87c1-e2a6-468b-9aae-771c029c53b6
November 24, 2022
1
November 16, 2022
November 24, 2022
1
November 16, 2022
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:
17350031913221
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined