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Flex

FDA UDI

Class I (US FDA UDI)

by Medrobotics Corporation

Identity

Trade Name
FLEX FDA UDI
Generic Name
Robotic surgical retractor FDA UDI
Device Name
TONGUE BLADE, 50-80MM X 32MM WIDE FDA UDI
Model / Reference
50123PKG FDA UDI
Description
TONGUE BLADE, 50-80MM X 32MM WIDE FDA UDI

Identifiers

Primary DI / UDI-DI
00850190004308 FDA UDI
FDA Product Code
KAL FDA UDI
GMDN Term
Robotic surgical retractor FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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

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: Robotic surgical retractor

Flex by Medrobotics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic surgical retractor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medrobotics Corporation

Sources (1)

  • FDA UDI ac3538cb-4ef4-4df1-aad9-86bb172ad37f 33 fields · synced May 30, 2026