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EpiSpin Lock

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
EpiSpin Lock FDA UDI
Generic Name
Epidural/intrathecal anaesthesia set, non-medicated FDA UDI
Device Name
EpiSpin Lock Tuohy with back eye and wings 16G x 90mm, Sprotte Standard with FDA UDI
Model / Reference
0021351-17 FDA UDI
Description
EpiSpin Lock Tuohy with back eye and wings 16G x 90mm, Sprotte Standard with FDA UDI

Identifiers

Catalog Number
0021351-17 FDA UDI
Primary DI / UDI-DI
04048223130643 FDA UDI
510(k) Number
K060563 FDA UDI
FDA Product Code
CAZ FDA UDI
GMDN Term
Epidural/intrathecal anaesthesia set, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5140 FDA UDI
Commercial Distribution
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

No

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

Yes

FDA UDI

Category: Epidural/intrathecal anaesthesia set, non-medicated

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

Similar devices

Also classified as Epidural/intrathecal anaesthesia set, non-medicated.

Cleared under the same submission

K060563 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 65aa0cbd-5128-45df-8985-3a0619811211 37 fields · synced May 30, 2026