← Back to catalogue

Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical FDA UDI
Generic Name
Cast/plaster saw FDA UDI
Device Name
zenith engel plaster saw, stainless blade, 6" (15.0 cm) FDA UDI
Model / Reference
N95177-16 FDA UDI
Description
zenith engel plaster saw, stainless blade, 6" (15.0 cm) FDA UDI

Identifiers

Catalog Number
N95177-16 FDA UDI
Primary DI / UDI-DI
G586N95177160 FDA UDI
FDA Product Code
LGG FDA UDI
GMDN Term
Cast/plaster saw FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cast/plaster saw

Novo Surgical by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cast/plaster saw.

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
Novo Surgical, Inc.

Sources (1)

  • FDA UDI 12cce1db-134e-4954-b1c5-c89dc808b4f9 35 fields · synced May 30, 2026