Identity
- Trade Name
- gDrill Bit, 6", SQC, 3 flutes, Ø 2.5mm, max ID 1.2mm cann, 20mm EUDAMEDgSource FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Rod Cutter EUDAMEDgDrill Bit, 6", SQC, 3 flutes, Ø 2.5mm, max ID 1.2mm cann, 20mm FDA UDI
- Model / Reference
- gS 86.8825 EUDAMEDFDA UDI
- Description
- gDrill Bit, 6", SQC, 3 flutes, Ø 2.5mm, max ID 1.2mm cann, 20mm FDA UDI
Identifiers
- Catalog Number
- gS 86.8825 FDA UDI
- Primary DI / UDI-DI
- 00840314269898 EUDAMEDFDA UDI
- Basic UDI-DI
- 08403142CUTTINGKB EUDAMED
- Direct Marketing DI
- 00840314269898 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L1104 BITS FOR NEUROSURGERY DRILLS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland 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
No
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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Fluted surgical drill bit, reusable
gSource by Gsource, Llc. — 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
- Gsource, Llc.
Sources (2)
- FDA UDI dff25f97-ce58-4ae4-8e0b-ebfdf166942a 34 fields · synced Jun 19, 2026
- EUDAMED 5a26c623-386c-42b7-9e5f-02218017862a 61 fields · synced Jun 19, 2026