Identity
- Trade Name
- HiCUT Burs FDA UDI
- Generic Name
- Cranial bur, single-use FDA UDI
- Model / Reference
- 3.0 mm neuro Matchstick Diamond FDA UDI
Identifiers
- Catalog Number
- 15-ND30 FDA UDI
- Primary DI / UDI-DI
- 04251388957554 FDA UDI
- 510(k) Number
- K130755 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Cranial bur, 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cranial bur, single-use
HiCUT Burs by adeor Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cranial bur, single-use.
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- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- J-Notch Burs — Stryker Instruments · Class IIa
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- Einmal-Schere Metzenbaum, stumpf/stumpf, fein, gebogen, 11, 5 cm, unsteril — Fuhrmann GmbH · Class IIa
Cleared under the same submission
K130755 also covers:
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
- HiCUT Burs — adeor Medical AG
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
- adeor Medical AG
Sources (1)
- FDA UDI 66b866b7-955b-402b-ac01-62e43491bb6a 34 fields · synced May 30, 2026