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Tissue-Tek® Paraform®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name
Tissue-Tek® Paraform® FDA UDI
Generic Name
Histological tissue cassette biopsy insert IVD FDA UDI
Device Name
3-mm Punch Gels; 500/case FDA UDI
Model / Reference
7049 FDA UDI
Description
3-mm Punch Gels; 500/case FDA UDI

Identifiers

Catalog Number
7049 FDA UDI
Primary DI / UDI-DI
10615233081220 FDA UDI
FDA Product Code
IDZ FDA UDI
GMDN Term
Histological tissue cassette biopsy insert IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Histological tissue cassette biopsy insert IVD

Tissue-Tek® Paraform® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Histological tissue cassette biopsy insert IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sakura Finetek USA, Inc

Sources (1)

  • FDA UDI 7971b08e-c412-4076-be40-b62b3fa33a71 35 fields · synced Jun 8, 2026