Identity
- Trade Name
- exsalt CMC Gelling Fiber Dressing FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/cm2) (1.7wt/wt%). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against Gram-positive and Gram-negative bacteria. exsalt™ CMC Gelling Fiber Dressing absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. FDA UDI
- Model / Reference
- PN-09-0125 FDA UDI
- Description
- exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/cm2) (1.7wt/wt%). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against Gram-positive and Gram-negative bacteria. exsalt™ CMC Gelling Fiber Dressing absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. FDA UDI
Identifiers
- Catalog Number
- GF0112 FDA UDI
- Primary DI / UDI-DI
- 07540127000284 FDA UDI
- 510(k) Number
- K162508 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
Yes
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
MR Unsafe FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
exsalt CMC Gelling Fiber Dressing by Exciton Technologies Inc — 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
- Calcium Alginate Ag Dressing 6"x6" — Gentell · U
Cleared under the same submission
K162508 also covers:
- KerraCel Ag — CRAWFORD HEALTHCARE LIMITED
- KerraCel Ag — CRAWFORD HEALTHCARE LIMITED
- KerraCel Ag — CRAWFORD HEALTHCARE LIMITED
- KerraCel Ag — CRAWFORD HEALTHCARE LIMITED
- KerraCel Ag — CRAWFORD HEALTHCARE LIMITED
- KerraCel Ag — CRAWFORD HEALTHCARE LIMITED
- KerraCel Ag — CRAWFORD HEALTHCARE LIMITED
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc
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
- Exciton Technologies Inc
Sources (1)
- FDA UDI 34f5b648-456b-48c2-9401-563e84982161 38 fields · synced Jun 1, 2026