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Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical FDA UDI
Generic Name
Dura mater knife FDA UDI
Device Name
zenith bucy cordotomy knife, 1/2" (6.0 mm) blade, 6-1/2" (16.5 cm), forward cutting FDA UDI
Model / Reference
N96849-62 FDA UDI
Description
zenith bucy cordotomy knife, 1/2" (6.0 mm) blade, 6-1/2" (16.5 cm), forward cutting FDA UDI

Identifiers

Catalog Number
N96849-62 FDA UDI
Primary DI / UDI-DI
G586N96849620 FDA UDI
FDA Product Code
HAO FDA UDI
GMDN Term
Dura mater knife FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4535 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: Dura mater knife

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

Similar devices

Also classified as Dura mater knife.

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 fc7e54f2-d7fd-46e6-b8f0-701fc909a5a5 35 fields · synced May 30, 2026