Identity
- Trade Name
- Disposable Applicator Cover FDA UDI
- Generic Name
- Electromagnetic stimulation system application pad FDA UDI
- Device Name
- Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers. FDA UDI
- Model / Reference
- PVTC30 FDA UDI
- Description
- Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20868924000018 FDA UDI
- FDA Product Code
- ILX FDA UDI
- GMDN Term
- Electromagnetic stimulation system application pad FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5290 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Disposable Applicator Cover by Regenesis Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Regenesis Biomedical, Inc.
Sources (1)
- FDA UDI 2fb830a0-e266-4999-a113-48a2a984cf5b 35 fields · synced Jun 8, 2026