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Saw Blades for Endoprosthetics, Sterile

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 54780107

by Gebr. Brasseler GmbH & Co. KG

Identity

Trade Name
Sawblade EZ FDA UDI
Generic Name
Surgical saw blade, sagittal, reusable FDA UDI
Device Name
Saw Blades for Endoprosthetics, Sterile EUDAMED
Saw Blade EZ for MicroAire®, S&N Dyonics® 90,00 x 19,05 x 1,27 (x 1,27)mm FDA UDI
Model / Reference
54780107 EUDAMEDFDA UDI
Description
Saw Blade EZ for MicroAire®, S&N Dyonics® 90,00 x 19,05 x 1,27 (x 1,27)mm FDA UDI

Identifiers

Catalog Number
54780107 FDA UDI
Primary DI / UDI-DI
14053613208687 EUDAMEDFDA UDI
Basic UDI-DI
++E226533028SR4 EUDAMED
Direct Marketing DI
04053613208680 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 EUDAMED
Class 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

Saw Blades for Endoprosthetics, Sterile by Gebr. Brasseler GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gebr. Brasseler GmbH & Co. KG
EUDAMED SRN
DE-MF-000006446

Sources (2)

  • EUDAMED 6ca48981-4a7d-4bcd-838f-f9a8c7800983 61 fields · synced Jun 19, 2026
  • FDA UDI 28e3c61d-f429-4097-8c3e-30c1e5e6c45d 34 fields · synced May 30, 2026