Identity
- Trade Name
- RECT. SHAPE 8X4.8cm (M) FDA UDI
- Generic Name
- External manual massager, clinical FDA UDI
- Model / Reference
- Guasha.M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14897076722003 FDA UDI
- FDA Product Code
- KNM FDA UDI
- GMDN Term
- External manual massager, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5765 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: External manual massager, clinical
RECT. SHAPE 8X4.8cm (M) by Tens Plus Industrial Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tens Plus Industrial Company
Sources (1)
- FDA UDI a1a8ef7f-6033-43c8-881e-62beda053495 32 fields · synced Jun 1, 2026