Bone Resector, Bullet Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- Bone Resector, Bullet Tip EUDAMEDbone resector FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Bone Resector, Bullet Tip EUDAMEDFDA UDIBarrel Cutter, Barrel Tip, with distal protection EUDAMED
- Model / Reference
- JSBBT273533 EUDAMEDFDA UDIJSBBT194543 EUDAMEDFDA UDIJSBBT244543 EUDAMEDFDA UDIJSBBT274543 EUDAMEDFDA UDI
- Description
- Bone Resector, Bullet Tip FDA UDI
Identifiers
- Catalog Number
- JSBBT274543 FDA UDIJSBBT273533 FDA UDIJSBBT194543 FDA UDIJSBBT244543 FDA UDI
- Primary DI / UDI-DI
- 04250337116370 EUDAMEDFDA UDI04250337115533 EUDAMEDFDA UDI04250337115472 EUDAMEDFDA UDI04250337116394 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337116370 EUDAMEDB-04250337115533 EUDAMEDB-04250337115472 EUDAMEDB-04250337116394 EUDAMED42503371DEFLRESAK EUDAMED
- Direct Marketing DI
- 04250337115533 EUDAMED04250337115472 EUDAMED04250337116394 EUDAMED04250337116370 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Poland EUDAMEDGermany EUDAMEDSpain 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: Spinal shaver system blade
Bone Resector, Bullet Tip by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal shaver system blade.
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Disposable Burs — Hicren (Zhejiang) Medtech Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
- Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337116370 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337116370 | 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 (13)
- EUDAMED d57a8d8d-25ae-4a34-9003-1bcbb7157f1f 61 fields · synced Aug 1, 2026
- EUDAMED 06aadde7-1f96-44b3-becf-e9783b6848d6 61 fields · synced May 17, 2026
- EUDAMED 92b72809-728f-48f5-973d-471841e65fec 61 fields · synced May 18, 2026
- EUDAMED f15712cf-f49d-4e98-8971-6c446aa328f1 61 fields · synced May 18, 2026
- FDA UDI 8b5e4ea4-f062-408a-9c0f-1dcba16b25ed 36 fields · synced May 30, 2026
- FDA UDI 0436d07c-7784-44c9-8d3a-21eb28a253df 36 fields · synced May 30, 2026
- FDA UDI 40a4298d-a8e2-444a-98c4-ff787c02e2e2 36 fields · synced May 30, 2026
- FDA UDI fc4d37ef-9d63-4c2d-a32b-2a707f942ba9 36 fields · synced May 30, 2026
- EUDAMED 0cbdc27e-fd4d-4dab-b166-5dee8cd605de 61 fields · synced Jul 13, 2026
- EUDAMED c143d1d9-c262-4057-a44d-aa8b9c1a8cba 61 fields · synced Jul 29, 2026
- EUDAMED 04d1f2b6-a6d2-4391-bd27-b26a6cb8a230 61 fields · synced Jul 30, 2026
- EUDAMED 4f8ba94e-197e-4a5b-90ef-90aeacc1365b 61 fields · synced Jul 31, 2026
- EUDAMED 11c2a7bd-16fb-4273-b4ac-3cf071f22950 61 fields · synced Aug 1, 2026