Identity
- Trade Name
- Oscillating Saw Blade FDA UDI
- Generic Name
- Surgical saw blade, sagittal, single-use FDA UDI
- Device Name
- Saw blades for endoprosthetics single use EUDAMEDOscillating Saw Blade - for Linvatec® Hall® 100x13x1.27mm FDA UDI
- Model / Reference
- 05.003.637S EUDAMEDFDA UDI
- Description
- Oscillating Saw Blade - for Linvatec® Hall® 100x13x1.27mm FDA UDI
Identifiers
- Catalog Number
- 05.003.637S FDA UDI
- Primary DI / UDI-DI
- 14053613284308 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2265330303N EUDAMED
- FDA Product Code
- GFA FDA UDI
- EMDN Code
- P091305 BONE SAWS, SINGLE-USE EUDAMED
- GMDN Term
- Surgical saw blade, sagittal, single-use 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
Yes
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: Surgical saw blade, sagittal, single-use
Oscillating Saw Blade by Gebr. Brasseler GmbH & Co. KG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical saw blade, sagittal, single-use.
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- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- IMEDICOM SAW BLADE — IMEDICOM CO., LTD. · Class I
- Arthrex® — Arthrex, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gebr. Brasseler GmbH & Co. KG
Sources (2)
- FDA UDI 2b1fa7e4-5d81-4d21-b781-25c13aa36d19 34 fields · synced Oct 8, 2026
- EUDAMED ae309762-c0c8-4286-9c7d-80d08bb5a5ba 61 fields · synced Oct 8, 2026