Identity
- Trade Name
- Drill Bit Cranial 4.5 mm /4.9 mm FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Model / Reference
- 56405-07 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481145910 FDA UDI
- 510(k) Number
- K243698 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
Category: Fluted surgical drill bit, single-use
Drill Bit Cranial 4.5 mm /4.9 mm by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243698 also covers:
- Alignment Software Cranial with LITT — Brainlab AG
- Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm — Brainlab SE
- Alignment Guide Tube Cranial 4.9 mm / 8.0 mm — Brainlab SE
- Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm — Brainlab SE
- Cirq Arm System 2.0 — Brainlab SE
- Curve Navigation 17700 — Brainlab SE
- Drill Depth Stop Cranial 4.9 mm — Brainlab SE
- Sterilization Tray Cirq® Robotic Alignment LITT — Brainlab SE
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
- Brainlab SE
Sources (1)
- FDA UDI 9041f4b4-da8c-4573-ba1c-303256bf6857 33 fields · synced May 31, 2026