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Saw Blades for Endoprosthetics, Sterile
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 54780092
Identity
- Trade Name
- Sawblade EZ FDA UDI
- Generic Name
- Surgical saw blade, sagittal, reusable FDA UDI
- Device Name
- Saw Blades for Endoprosthetics, Sterile EUDAMEDSawblade EZ for Stryker® 90,00 x 13,00 x 1,37 (x 1,37)mm FDA UDI
- Model / Reference
- 54780092 EUDAMEDFDA UDI
- Description
- Sawblade EZ for Stryker® 90,00 x 13,00 x 1,37 (x 1,37)mm FDA UDI
Identifiers
- Catalog Number
- 54780092 FDA UDI
- Primary DI / UDI-DI
- 14053613070925 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E226533028SR4 EUDAMED
- Direct Marketing DI
- 04053613070928 EUDAMED
- FDA Product Code
- GFA FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical saw blade, sagittal, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone cutting forceps, reusable
Saw Blades for Endoprosthetics, Sterile by Gebr. Brasseler GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | ++E226533028SR4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Gebr. Brasseler GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006446
Sources (2)
- EUDAMED e54924a6-e062-4f9e-9c81-1dae5a84141a 61 fields · synced Jun 19, 2026
- FDA UDI a885e078-938c-4876-a519-592aa92640d2 34 fields · synced May 29, 2026