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: sorensen-type micro forceps, 8.0 mm wide round handle, 45 degree angle, 0.2 mm tip size, counterbalanced handle, 6" (150.0 mm) FDA UDI
Model / Reference: 78FRAS-15RM8 FDA UDI
Description: sorensen-type micro forceps, 8.0 mm wide round handle, 45 degree angle, 0.2 mm tip size, counterbalanced handle, 6" (150.0 mm) FDA UDI

Identifiers

Catalog Number: 78FRAS-15RM8 FDA UDI
Primary DI / UDI-DI: 00842331173387 FDA UDI
FDA Product Code: GEN FDA UDI
GMDN Term: Open-surgery biopsy forceps, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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 Inc. 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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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 ad87d93f-2c6e-4348-908c-5cf263d1ee6d 35 fields · synced May 30, 2026