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Novo Surgical Inc.

FDA UDI

Class I (US FDA UDI)

by Novo Surgical, Inc.

Identity

Trade Name
Novo Surgical Inc. FDA UDI
Generic Name
Surgical fluid/gas irrigator FDA UDI
Device Name
graether collar button, iris retractor, posterior surface for capsule polishing, 23-gauge, 1" (2.5 cm), angled FDA UDI
Model / Reference
OP7124-99 FDA UDI
Description
graether collar button, iris retractor, posterior surface for capsule polishing, 23-gauge, 1" (2.5 cm), angled FDA UDI

Identifiers

Catalog Number
OP7124-99 FDA UDI
Primary DI / UDI-DI
00842331175657 FDA UDI
FDA Product Code
HMX FDA UDI
GMDN Term
Surgical fluid/gas irrigator 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical fluid/gas irrigator

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

Similar devices

Also classified as Surgical fluid/gas irrigator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novo Surgical, Inc.

Sources (1)

  • FDA UDI 7a6799e1-d354-4f46-83ff-bdb7b8fb46eb 35 fields · synced May 30, 2026