Identity
- Trade Name
- Zetuvit Plus Silicone Border 16x26cm FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
- Device Name
- Zetuvit Plus Silicone Border 16x26cm FDA UDI
- Model / Reference
- 413904 Zetuvit Plus Silicone Border 16x26cm FDA UDI
- Description
- Zetuvit Plus Silicone Border 16x26cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052199580456 FDA UDI
- FDA Product Code
- NAC FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 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
Yes
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, non-antimicrobial
Zetuvit Plus Silicone Border 16x26cm by Paul Hartmann Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial.
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- Eclypse Adherent — BRIGHTWAKE LIMITED · Class I
- Cutimed® Sorbion® — BSN MEDICAL, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Paul Hartmann Corp.
Sources (1)
- FDA UDI b83dd398-a13e-475f-a241-8046b981c9d3 33 fields · synced May 30, 2026