← Back to catalogue
Hollow Reamers 5.0mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref HR1011969
by Tecomet, Inc
Identity
- Trade Name
- Hollow Reamers 5.0mm EUDAMEDTecomet FDA UDI
- Generic Name
- Bone trephine, reusable FDA UDI
- Device Name
- Trephines EUDAMEDReamer Assembly, Hollow 5mm 1/4" Male Square Drive FDA UDI
- Model / Reference
- HR1011969 EUDAMEDFDA UDI
- Description
- Reamer Assembly, Hollow 5mm 1/4" Male Square Drive FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069013769 EUDAMEDFDA UDI
- Basic UDI-DI
- 08180690114147KY EUDAMED
- Direct Marketing DI
- 00818069013769 EUDAMED
- FDA Product Code
- HWB FDA UDI
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
- GMDN Term
- Bone trephine, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
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
Category: Bone trephine, reusable
Hollow Reamers 5.0mm by Tecomet, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone trephine, reusable.
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- DENTECH — Dentech Corp. · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Borchardt Flat Trephine 5 mm Borchardt Shaft Ø 1.8 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08180690114147KY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecomet, Inc
- EUDAMED SRN
- US-MF-000027544
- Authorised Representative
- Meditec Source GmbH & Co. KG DE-AR-000009318
Sources (2)
- EUDAMED ec0c1863-3b14-4ddf-9217-e8f7da29cc18 61 fields · synced Sep 18, 2026
- FDA UDI 8fe88430-ad5a-4911-b5e8-12528f442165 33 fields · synced May 29, 2026