Identity
- Trade Name
- EZX Blade FDA UDI
- Generic Name
- Surgical saw blade, sagittal, single-use FDA UDI
- Model / Reference
- XTB600 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038036321 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Surgical saw blade, sagittal, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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-useSurgical saw blade, reciprocating, single-use
EZX Blade by Imedicom Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Imedicom Co., Ltd.
Sources (1)
- FDA UDI c44fa6a2-b27b-44c3-9804-0863867b3573 32 fields · synced May 30, 2026