Novo Surgical

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name: Novo Surgical FDA UDI
Generic Name: Intraocular retractor, reusable FDA UDI
Device Name: mackool lens capsule retractor, 1.0 mm hook suspended 0.5 mm from end of tip, 45 degrees angled shaft, 4 3/4" (12.0 cm) FDA UDI
Model / Reference: OP7120-54 FDA UDI
Description: mackool lens capsule retractor, 1.0 mm hook suspended 0.5 mm from end of tip, 45 degrees angled shaft, 4 3/4" (12.0 cm) FDA UDI

Identifiers

Catalog Number: OP7120-54 FDA UDI
Primary DI / UDI-DI: G586OP7120540 FDA UDI
FDA Product Code: HNI FDA UDI
GMDN Term: Intraocular retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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: Intraocular retractor, reusable

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

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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 96d0b37c-79aa-4544-ac67-db5509099f0b 35 fields · synced Jun 8, 2026