← Back to catalogue

Stablecut®

FDA UDI

Class I (US FDA UDI)

by Synvasive Technology, Inc.

Identity

Trade Name
Stablecut® FDA UDI
Generic Name
Surgical saw blade, oscillating, single-use FDA UDI
Model / Reference
11-3586 FDA UDI

Identifiers

Primary DI / UDI-DI
00846795002382 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
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 saw blade, oscillating, single-use

Stablecut® by Synvasive Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical saw blade, oscillating, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Synvasive Technology, Inc.

Sources (1)

  • FDA UDI d8610d59-8364-438a-a9e0-231fc9bbab80 33 fields · synced May 31, 2026