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EpiSpin II SAFETY

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
EpiSpin II SAFETY FDA UDI
Generic Name
Epidural/intrathecal anaesthesia set, non-medicated FDA UDI
Device Name
EpiSpin II SAFETY Tuohy with backeye and wings 18G x 90cm, Sprotte Standard with FDA UDI
Model / Reference
0021451-30 FDA UDI
Description
EpiSpin II SAFETY Tuohy with backeye and wings 18G x 90cm, Sprotte Standard with FDA UDI

Identifiers

Catalog Number
0021451-30 FDA UDI
Primary DI / UDI-DI
04048223072639 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

Dimensions & Sizes

Size
Length — 90.0 Millimeter FDA UDI
Needle Gauge — 18.0 Gauge FDA UDI

Category: Epidural/intrathecal anaesthesia set, non-medicated

EpiSpin II SAFETY 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.

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 6a5a1a87-a245-4197-9b8b-1420d5e6c956 37 fields · synced May 30, 2026