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OMNIBotics

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name
OMNIBotics FDA UDI
Generic Name
Robotic surgical navigation system application software FDA UDI
Device Name
Disk Image for CF532S FDA UDI
Model / Reference
NS-27013 FDA UDI
Description
Disk Image for CF532S FDA UDI

Identifiers

Catalog Number
NS-27013 FDA UDI
Primary DI / UDI-DI
00841690194477 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Robotic surgical navigation system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Robotic surgical navigation system application software

OMNIBotics by OMNIlife science, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical navigation system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OMNIlife science, Inc.

Sources (1)

  • FDA UDI cc69c791-343d-4fd8-ae24-656f0bd852d6 35 fields · synced Jun 9, 2026