Identity
- Trade Name
- ZAGUAR FDA UDI
- Generic Name
- Surgical power tool system handpiece, rotary, rechargeable battery-powered FDA UDI
- Model / Reference
- BH101S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038037021 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Surgical power tool system handpiece, rotary, rechargeable battery-powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical power tool system handpiece, rotary, rechargeable battery-powered
Zaguar by Imedicom Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system handpiece, rotary, rechargeable battery-powered.
- Surgical handpiece 1:1 — Nouvag AG · Class II
- Handle complete for CHP Handpiece — Nouvag AG · Class I
- Surgical handpiece 1:1 — Nouvag AG · Class II
- Surgical handpiece 1:1 — Nouvag AG · Class II
- DYONICS — Smith & Nephew, Inc. · Class I
- Angled handpiece for MIS spinal surgery burrs — Nouvag AG · Class I
- Handpiece for MIS spinal surgery burrs — Nouvag AG · Class I
- DragonFly™, POWERED BY InvisiDrive™ HANDPIECE — Grace Medical, Inc. · Class II
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
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI e7ca226e-ef70-4acc-b376-22e3d23a8f0c 32 fields · synced Jun 6, 2026