Novo Surgical Inc

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical Inc FDA UDI
Generic Name: Open-surgery biopsy forceps, reusable FDA UDI
Device Name: kern bone holding forceps, w/ ratchet, 9 1/2" (24.1 cm) FDA UDI
Model / Reference: N4646-35 FDA UDI
Description: kern bone holding forceps, w/ ratchet, 9 1/2" (24.1 cm) FDA UDI

Identifiers

Primary DI / UDI-DI: 00842331193231 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Open-surgery biopsy forceps, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery biopsy forceps, reusable

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

Similar devices

Also classified as Open-surgery biopsy forceps, reusable.

LAZIC — Peter Lazic GmbH · Class I
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Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
ARTHROSCOPIC GRASPING RONGEUR FORCEPS — SONTEC INSTRUMENTS, INC. · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
LAZIC — Peter Lazic GmbH · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I

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: Novo Surgical, Inc.

Sources (1)

FDA UDI aab28150-30c6-4411-a86e-d0d5cdd86504 33 fields · synced Jun 1, 2026