Identity
- Trade Name
- PRIMASEAL FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- Silver Surgical Hydrocolloid (SSHCD) FDA UDI
- Model / Reference
- Ag Postoperative Ionic Silver FDA UDI
- Description
- Silver Surgical Hydrocolloid (SSHCD) FDA UDI
Identifiers
- Catalog Number
- MSCPS310 FDA UDI
- Primary DI / UDI-DI
- 10888277717091 FDA UDI
- 510(k) Number
- K180634 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
Primaseal by Medline Industries, 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
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc · U
Cleared under the same submission
K180634 also covers:
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL — MEDLINE INDUSTRIES, INC.
- PRIMASEAL Post-Op Ag — MEDLINE INDUSTRIES, 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 |
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Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI 062cac51-ea5c-4866-a26f-25bc789ea3ad 35 fields · synced May 30, 2026