Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Open-surgery biopsy forceps, reusable FDA UDI
Device Name: tischler biopsy forceps, 3.0 mm x 7.0 mm bite, tip angled up, standard style, 10" (25.4 cm) working length FDA UDI
Model / Reference: OB6375-37 FDA UDI
Description: tischler biopsy forceps, 3.0 mm x 7.0 mm bite, tip angled up, standard style, 10" (25.4 cm) working length FDA UDI

Identifiers

Catalog Number: OB6375-37 FDA UDI
Primary DI / UDI-DI: G586OB6375370 FDA UDI
FDA Product Code: HFB FDA UDI
GMDN Term: Open-surgery biopsy forceps, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

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Also classified as Open-surgery biopsy forceps, reusable.

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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 e92cfc66-6156-49f3-84ec-0c6ed2e6ee00 35 fields · synced May 30, 2026