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Gii
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 213207Model General Orthopedic Use Aiming and Guiding Instruments
Identity
- Trade Name
- Slotted Drill Guide EUDAMEDGII FDA UDI
- Generic Name
- Manual surgical rotary handpiece, reusable FDA UDI
- Device Name
- Guide, Sawtooth, Slotted, Fishmouth, Shark, Drill Guide, Guidewire, Round, Trocar, Conical, Tip, Rod, Femoral, Tibial, Skid, Aimer, Offset, Femoral, Sleeve Removal Tool, Switching Stick, Bone Graft, Clear Cannula, Cap EUDAMEDSlotted Drill Guide GII / SUPER / RC / GLS FDA UDI
- Model / Reference
- 213207 EUDAMEDFDA UDIGeneral Orthopedic Use Aiming and Guiding Instruments EUDAMED
- Description
- Slotted Drill Guide GII / SUPER / RC / GLS FDA UDI
Identifiers
- Catalog Number
- 213207 FDA UDI
- Primary DI / UDI-DI
- 10886705002610 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00120K2 EUDAMED
- Direct Marketing DI
- 10886705002610 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Manual surgical rotary handpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual surgical rotary handpiece, reusable
Gii by Medos International Sàrl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (2)
- FDA UDI fae16646-778a-4cab-b6a6-d722861d3734 35 fields · synced Jun 18, 2026
- EUDAMED a5fb8db1-6e08-4be2-84b5-2c47096bd34e 61 fields · synced Jun 18, 2026