← Back to catalogue

SonoTAP II NRFit

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
SonoTAP II NRFit FDA UDI
Generic Name
Rapid-contact laboratory freezer FDA UDI
Device Name
SonoTAP II NRFit 24G x 50mm with bevel tip and Cornerstone Reflectors FDA UDI
Model / Reference
1265-3Y050 FDA UDI
Description
SonoTAP II NRFit 24G x 50mm with bevel tip and Cornerstone Reflectors FDA UDI

Identifiers

Catalog Number
1265-3Y050 FDA UDI
Primary DI / UDI-DI
04048223077962 FDA UDI
510(k) Number
K243525 FDA UDI
FDA Product Code
BSP FDA UDI
GMDN Term
Rapid-contact laboratory freezer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5150 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
Needle Gauge — 24.0 Gauge FDA UDI
Length — 50.0 Millimeter FDA UDI

Category: Rapid-contact laboratory freezer

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

Similar devices

Also classified as Rapid-contact laboratory freezer.

Cleared under the same submission

K243525 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pajunk GmbH Medizintechnologie

Sources (1)

  • FDA UDI 7f2afc4a-b935-4692-b33f-4cb6558f21a1 38 fields · synced Jun 8, 2026