joimax® Bone Drill, 4.0 mm, cannulated, sterile
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- joimax® Bone Drill, 4.0 mm, cannulated, sterile EUDAMEDBone drill FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- joimax® Bone Drill, 4.0 mm, cannulated, sterile EUDAMEDFDA UDI
- Model / Reference
- DCC114021 EUDAMEDFDA UDI
- Description
- joimax® Bone Drill, 4.0 mm, cannulated, sterile FDA UDI
Identifiers
- Catalog Number
- DCC114021 FDA UDI
- Primary DI / UDI-DI
- 04250337105114 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337105114 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General internal orthopaedic fixation system implantation kit
joimax® Bone Drill, 4.0 mm, cannulated, sterile by Joimax GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337105114 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (2)
- EUDAMED 206c0a36-72c0-4e40-b737-65e396d6ed70 61 fields · synced Jun 18, 2026
- FDA UDI 362a6ee8-585f-4f1a-a561-4ccbf1ad7876 36 fields · synced May 29, 2026