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Omni

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
OMNI FDA UDI
Generic Name
Rigid endoscopic scissors, single-use FDA UDI
Device Name
The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a trained gynecologist to provide fine dissection of soft intrauterine tissue. FDA UDI
Model / Reference
OMNI-S-001 FDA UDI
Description
The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a trained gynecologist to provide fine dissection of soft intrauterine tissue. FDA UDI

Identifiers

Catalog Number
OMNI-S-001 FDA UDI
Primary DI / UDI-DI
15420045515529 FDA UDI
FDA Product Code
NWW FDA UDI
GMDN Term
Rigid endoscopic scissors, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.1690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rigid endoscopic scissors, single-use

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

Similar devices

Also classified as Rigid endoscopic scissors, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI dee04aa9-2c64-4656-a66d-69f0da813654 35 fields · synced Jun 8, 2026