Identity
- Trade Name
- Universal Neuro 2, Universal Neuro 3 FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Drill for 18mm Screws, Dental Shaft FDA UDI
- Model / Reference
- 60-19918 FDA UDI
- Description
- Drill for 18mm Screws, Dental Shaft FDA UDI
Identifiers
- Catalog Number
- 60-19918 FDA UDI
- Primary DI / UDI-DI
- 04546540366610 FDA UDI
- 510(k) Number
- K070876 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 19.0 Millimeter FDA UDILength — 29.0 Millimeter FDA UDI
Category: Fluted surgical drill bit, single-use
Universal Neuro 2, Universal Neuro 3 by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070876 also covers:
- DELTA — Stryker Leibinger
- DELTA — Stryker Leibinger
- Delta — Stryker Leibinger
- Delta — Stryker Leibinger
- UNIVERSAL 2 — Stryker Leibinger
- Universal Neuro 2, Universal Neuro 3 — Stryker Leibinger
- Universal Neuro 2, Universal Neuro 3 — Stryker Leibinger
- Universal Neuro 2, Universal Neuro 3 — Stryker Leibinger
- Universal Neuro 2, Universal Neuro 3 — Stryker Leibinger
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
- Stryker Leibinger
Sources (1)
- FDA UDI 6d109a99-e91e-49d2-a583-c7ed4a4e849f 36 fields · synced May 30, 2026