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Calcium Alginate Ag (Silver) Dressing Rope (12 in)
FDA UDIClass U (US FDA UDI)
by Gentell
Identity
- Trade Name
- Calcium Alginate Ag (Silver) Dressing Rope (12 in) FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- Calcium Alginate Ag (Silver) 12" Rope Dressing FDA UDI
- Model / Reference
- GEN-13142 FDA UDI
- Description
- Calcium Alginate Ag (Silver) 12" Rope Dressing FDA UDI
Identifiers
- Catalog Number
- GEN-13142 FDA UDI
- Primary DI / UDI-DI
- 00361554001036 FDA UDI
- 510(k) Number
- K120181 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Calcium Alginate Ag (Silver) Dressing Rope (12 in) by Gentell — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
- DermaGinate/Ag — DERMARITE INDUSTRIES LLC · U
- AQUACEL AG+ — CONVATEC, PURCHASING DEPARTMENT · U
- 3M™ Silvercel™ — 3M Deutschland GmbH · U
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED · U
- Algitocare Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD. · U
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc · U
Cleared under the same submission
K120181 also covers:
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Zeni Medical — FOCUS HEALTH GROUP
- Calcium Alginate Ag (Silver) Dressing (2x2 in) — Gentell
- Calcium Alginate Ag (Silver) Dressing (4x4 in) — Gentell
- Calcium Alginate Ag (Silver) Dressing (4x8 in) — Gentell
- Calcium Alginate Ag (Silver) Dressing (8x8 in) — Gentell
- Calcium Alginate Ag Dressing 6"x6" — Gentell
- NuMed Industries LLC. — Numed Industries, LLC
- NuMed Industries LLC. — Numed Industries, LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gentell
Sources (1)
- FDA UDI 80bd49e8-3546-4a20-854c-60f86a451d2f 35 fields · synced May 30, 2026