Identity
- Trade Name
- Stablecut® FDA UDI
- Generic Name
- Surgical saw blade, oscillating, single-use FDA UDI
- Model / Reference
- 855540005 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846795009091 FDA UDI
- FDA Product Code
- GFA FDA UDI
- GMDN Term
- Surgical saw blade, oscillating, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Width — 13 Millimeter FDA UDILength — 70 Millimeter FDA UDI
Stablecut® by Synvasive Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Synvasive Technology, Inc.
Sources (1)
- FDA UDI f1b39bec-61e7-438b-86a7-b5fecc67479c 35 fields · synced May 30, 2026