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iotaSOFT Insertion System

FDA UDI

Class II (US FDA UDI)

by Iotamotion, Inc.

Identity

Trade Name
iotaSOFT Insertion System FDA UDI
Generic Name
Robotic surgical system application software FDA UDI
Device Name
iotaSOFT Footpedal FDA UDI
Model / Reference
IM-03 FDA UDI
Description
iotaSOFT Footpedal FDA UDI

Identifiers

Primary DI / UDI-DI
00850002960037 FDA UDI
510(k) Number
DEN190055 FDA UDI
FDA Product Code
QQH FDA UDI
GMDN Term
Robotic surgical system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4450 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Robotic surgical system application software

iotaSOFT Insertion System by Iotamotion, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical system application software.

Cleared under the same submission

DEN190055 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Iotamotion, Inc.

Sources (1)

  • FDA UDI 305cbbd4-c9c9-46c1-9dee-c0693f6ef844 34 fields · synced May 31, 2026