EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm EUDAMEDFDA UDI
- Generic Name
- Automatic cranial perforator, single-use FDA UDI
- Device Name
- EasyDrill Cranial Perforator EUDAMED
- Model / Reference
- DM0010FAA EUDAMEDFDA UDI
Identifiers
- Catalog Number
- DM0010FAA FDA UDI
- Primary DI / UDI-DI
- 07898959543593 EUDAMEDFDA UDI07898959543470 FDA UDI
- Basic UDI-DI
- 7898959543MDR0013E EUDAMED
- 510(k) Number
- K141455 FDA UDI
- FDA Product Code
- HBF FDA UDI
- EMDN Code
- Z12100902 DRILLS FOR NEUROSURGERY EUDAMED
- GMDN Term
- Automatic cranial perforator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4305 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Automatic cranial perforator, single-use
EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm by Micromar Indústria e Comércio Ltda — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Automatic cranial perforator, single-use.
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- ACRA-CUT — ACRA-CUT INC · Class II
Cleared under the same submission
K141455 also covers:
- EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø11 x Ø7 x 3mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda
- EasyDrill Cranial Perforator Ø14 x Ø11 x 3mm — Micromar Indústria e Comércio Ltda
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micromar Indústria e Comércio Ltda
Sources (3)
- FDA UDI 18a7621d-a9ab-4959-a418-c4d29073cb3f 37 fields · synced Jul 30, 2026
- FDA UDI babc7a1d-c2f4-4bbb-8778-952fe883b379 37 fields · synced May 29, 2026
- EUDAMED 6235cfe4-c1dd-4b73-9e04-1ad9cb8028bf 61 fields · synced Jul 30, 2026