Identity
- Trade Name
- RENCURA FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- Calcium Alginate Dressing with Silver 6X6 FDA UDI
- Model / Reference
- RCCS66 FDA UDI
- Description
- Calcium Alginate Dressing with Silver 6X6 FDA UDI
Identifiers
- Catalog Number
- RCCS66 FDA UDI
- Primary DI / UDI-DI
- 10665973032242 FDA UDI
- 510(k) Number
- K220673 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Rencura by Dukal LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
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Cleared under the same submission
K220673 also covers:
- RENCURA — Dukal LLC
- RENCURA — Dukal LLC
- RENCURA — Dukal LLC
- RENCURA — Dukal LLC
- Algitocare Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Algitocare Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Algitocare Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Algitocare Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
- Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Dukal LLC
Sources (1)
- FDA UDI 88c14054-2da0-426c-9cae-9c8f54737f4e 36 fields · synced May 30, 2026