Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical Inc. FDA UDI
Generic Name: Rib spreader, reusable FDA UDI
Device Name: balfour abdominal retractor w/ fixed side blades, w/ fixed fenestrated side blades, 2 1/2" deep & center blade #2470-72 (3" x 2"), 10" (25.4 cm) maximum spread FDA UDI
Model / Reference: G3581-31 FDA UDI
Description: balfour abdominal retractor w/ fixed side blades, w/ fixed fenestrated side blades, 2 1/2" deep & center blade #2470-72 (3" x 2"), 10" (25.4 cm) maximum spread FDA UDI

Identifiers

Catalog Number: G3581-31 FDA UDI
Primary DI / UDI-DI: 00842331186974 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Rib spreader, 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

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rib spreader, reusable

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

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Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
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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 059e61bf-bcdd-441a-8488-4c03f406c24b 35 fields · synced May 31, 2026