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Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm FDA UDI
- Generic Name
- Surgical power tool system handpiece, sawing, line-powered FDA UDI
- Model / Reference
- KM33-225 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B390KM332251 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Surgical power tool system handpiece, sawing, line-powered 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
No
FDA UDI
Category: Surgical power tool system handpiece, sawing, line-powered
Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm by Suretek Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool system handpiece, sawing, line-powered.
- SOH oscillating saw HP — OSADA ELECTRIC CO., LTD. · Class II
- Micro compass saw MSS 5000 — Nouvag AG · Class I
- DYONICS POWER — Smith & Nephew, Inc. · Class I
- SSH saggittal saw HP — OSADA ELECTRIC CO., LTD. · Class II
- DYONICS POWER — Smith & Nephew, Inc. · Class I
- Saw Disk — DENTIS CO. , LTD · Class I
- Saw Disk — DENTIS CO. , LTD · Class I
- DYONICS POWER — Smith & Nephew, Inc. · 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
- Suretek Medical
Sources (1)
- FDA UDI 0fc94ae2-5e89-4c17-b18d-30022f63a734 32 fields · synced May 31, 2026