Identity
- Trade Name
- ProCure FDA UDI
- Generic Name
- Pressure-ulcer topical dressing FDA UDI
- Device Name
- ProCure - Oil Emulsion Non Adhering Dressing 3"x16" 36ea/bx 8bx/cs FDA UDI
- Model / Reference
- PCHO3016 FDA UDI
- Description
- ProCure - Oil Emulsion Non Adhering Dressing 3"x16" 36ea/bx 8bx/cs FDA UDI
Identifiers
- Catalog Number
- PCHO3016 FDA UDI
- Primary DI / UDI-DI
- 10840330703311 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Pressure-ulcer topical dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Inch FDA UDIWidth — 3 Inch FDA UDI
Category: Pressure-ulcer topical dressing
ProCure by Twin Med, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure-ulcer topical dressing.
- Oil Emulsion Dressing — Dynarex Corp. · Class I
- Oil Emulsion Dressing — Dynarex Corp. · Class I
- Oil Emulsion Dressing — Dynarex Corp. · Class I
- ProCure — Twin Med, LLC · Class I
- ProCure — Twin Med, LLC · Class I
- ProCure — Twin Med, LLC · 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
- Twin Med, LLC
Sources (1)
- FDA UDI 5b99492c-9cbd-4ac6-adf2-78ea69b4b0ba 37 fields · synced Jun 7, 2026