Identity
- Trade Name
- Algitocare Sterile Silver Alginate Wound Dressing FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Model / Reference
- YF04 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934889086081 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
Yes
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
Yes
FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Algitocare Sterile Silver Alginate Wound Dressing by Qingdao Bright Moon Biomaterialco., Ltd. — Class U — FDA UDI — listed in FDA GUDID
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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
- 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.
- 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
- Qingdao Bright Moon Biomaterialco., Ltd.
Sources (1)
- FDA UDI aba261e4-dd2d-40d3-b77b-503f15b57b2a 33 fields · synced May 31, 2026