Identity
- Trade Name
- Inion instrument FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- 2.0 mm self tapping drill bit (J-latch) FDA UDI
- Model / Reference
- 0 FDA UDI
- Description
- 2.0 mm self tapping drill bit (J-latch) FDA UDI
Identifiers
- Catalog Number
- INS-9013 FDA UDI
- Primary DI / UDI-DI
- M224INS90139 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Inion instrument by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
- 1.5 mm Inion CPS® Baby — Inion , Ltd.
K010352 also covers:
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 1.5 mm Inion CPS® — Inion , Ltd.
- 2.0 mm Inion CPS® — Inion , Ltd.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion , Ltd.
Sources (1)
- FDA UDI 7ed518fa-39bc-4cfc-805f-257dc9284d85 36 fields · synced Jun 6, 2026