DEVICE: Alginate Wound Dressing (06934889085046)
Device Identifier (DI) Information
Alginate Wound Dressing
4in×8in (10cm*20cm)
In Commercial Distribution
QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
4in×8in (10cm*20cm)
In Commercial Distribution
QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
No description.
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? |
|---|---|---|---|---|
| 47474 | Exudate-absorbent dressing, hydrophilic-gel, 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, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It 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 while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.
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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 |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
a10b8e91-6d06-4467-be78-4de4c622ccb5
May 06, 2025
1
April 28, 2025
May 06, 2025
1
April 28, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 16934889085142 | 5 | 06934889085046 | In Commercial Distribution | ||
| 26934889085248 | 72 | 16934889085142 | In Commercial Distribution | ||
| 16934889085241 | 10 | 06934889085046 | In Commercial Distribution | ||
| 26934889085347 | 42 | 16934889085241 | In Commercial Distribution |
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
[?]
No Customer Contact currently defined