DEVICE: RENCURA (10665973032259)
Device Identifier (DI) Information
RENCURA
RCCS48
In Commercial Distribution
RCCS48
Dukal LLC
RCCS48
In Commercial Distribution
RCCS48
Dukal LLC
Calcium Alginate Dressing with Silver 4X8
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FRO | Dressing, wound, drug |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K220673 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
33591d52-c3a0-455e-9e85-a014c4e21e58
November 12, 2024
1
November 04, 2024
November 12, 2024
1
November 04, 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 |
|---|---|---|---|---|---|
| 20665973032256 | 5 | 10665973032259 | In Commercial Distribution | Box | |
| 30665973032253 | 40 | 20665973032256 | In Commercial Distribution | Case |
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
[?]
+1(631)656-3800
172
kmckigney@dukal.com
kmckigney@dukal.com