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Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical Inc. FDA UDI
Generic Name
Orthopaedic chisel FDA UDI
Device Name
stille style chisels, straight, 8" (20.0 cm), 18.0 mm FDA UDI
Model / Reference
N3954-31 FDA UDI
Description
stille style chisels, straight, 8" (20.0 cm), 18.0 mm FDA UDI

Identifiers

Catalog Number
N3954-31 FDA UDI
Primary DI / UDI-DI
00842331183249 FDA UDI
FDA Product Code
KDG FDA UDI
GMDN Term
Orthopaedic chisel 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic chisel

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

Similar devices

Also classified as Orthopaedic chisel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Surgical, Inc.

Sources (1)

  • FDA UDI 9341f301-10f1-4136-bd06-88fffde4f892 35 fields · synced May 30, 2026