Identity
- Trade Name
- VARIOSONIC FDA UDI
- Generic Name
- Surgical coverall FDA UDI
- Model / Reference
- 5333-104 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00366975048004 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Surgical coverall FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical coverall
Variosonic by Benco Dental Supply Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical coverall.
- Dukal — Dukal LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Dukal — Dukal LLC · Class I
- Dukal — Dukal LLC · Class I
- INDALJIMTM — Indaljim, S.A. de C.V. · Class I
- ASP MEDICAL — Asp Global, LLC · Class I
- TSW — Xiantao TSW Protective Products Co., Ltd · Class I
- ASP MEDICAL — Asp Global, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Benco Dental Supply Co.
Sources (1)
- FDA UDI 5f040e13-1a3d-4b4a-b254-babf7016f7d0 32 fields · synced Jun 6, 2026