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Tuohy NRFit

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
Tuohy NRFit FDA UDI
Generic Name
Epidural needle, non-threaded FDA UDI
Device Name
Tuohy NRFit 20G x 90mm plastic stylet and wings, FDA UDI
Model / Reference
1166-6G091 FDA UDI
Description
Tuohy NRFit 20G x 90mm plastic stylet and wings, FDA UDI

Identifiers

Catalog Number
1166-6G091 FDA UDI
Primary DI / UDI-DI
14048223028749 FDA UDI
510(k) Number
K160297 FDA UDI
FDA Product Code
BSP FDA UDI
GMDN Term
Epidural needle, non-threaded FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5150 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Tuohy NRFit by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160297 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pajunk GmbH Medizintechnologie

Sources (1)

  • FDA UDI 76e6d7c1-5302-407b-b282-819fd38a6df9 37 fields · synced Jun 7, 2026