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Flex-X

FDA UDI

Class II (US FDA UDI)

by Karl Storz GmbH & Co. KG

Identity

Trade Name
Flex-X FDA UDI
Generic Name
Flexible fibreoptic intracranial/spinal endoscope FDA UDI
Device Name
Video Neuro-Endoscope, flexible FDA UDI
Model / Reference
11161V FDA UDI
Description
Video Neuro-Endoscope, flexible FDA UDI

Identifiers

Primary DI / UDI-DI
04048551338988 FDA UDI
510(k) Number
K171402 FDA UDI
FDA Product Code
EOB FDA UDI
GMDN Term
Flexible fibreoptic intracranial/spinal endoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4760 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

No

FDA UDI

Category: Flexible fibreoptic intracranial/spinal endoscope

Flex-X by Karl Storz GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic intracranial/spinal endoscope.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Karl Storz GmbH & Co. KG

Sources (1)

  • FDA UDI aefd58a8-395a-497e-96ea-d46674297dc9 34 fields · synced Jun 1, 2026