Imedicom Saw Blade
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Saw Blade EUDAMEDIMEDICOM SAW BLADE FDA UDI
- Generic Name
- Surgical saw blade, reciprocating, single-use FDA UDISurgical saw blade, sagittal, single-use FDA UDI
- Device Name
- Sterile single use surgical blades EUDAMED
- Model / Reference
- BAO-410A EUDAMEDFDA UDICAR-BLADE-03 EUDAMEDBPO-220B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809288933152 EUDAMEDFDA UDI08809288937143 FDA UDI
- Basic UDI-DI
- B-08809288933152 EUDAMED
- FDA Product Code
- GFA FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical saw blade, reciprocating, single-use FDA UDISurgical 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
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
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: Surgical saw blade, sagittal, single-useSurgical saw blade, reciprocating, single-use
Imedicom Saw Blade by Imedicom Co., Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical saw blade, reciprocating, single-use.
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KG · Class I
- Stablecut® — Zimmer Orthopaedic Surgical Products · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- OXFORD PARTIAL KNEE — Biomet Orthopedics, Inc. · Class I
- KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KG · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Imedicom Co., Ltd.
Sources (3)
- FDA UDI 4671bcb7-6b78-4a37-ae64-5e898820511f 32 fields · synced Sep 17, 2026
- FDA UDI 7c115194-0980-4cd8-b1af-c2e9939786c6 32 fields · synced May 30, 2026
- EUDAMED 5d8660e5-88b3-4991-b966-e03864713845 61 fields · synced Sep 17, 2026