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Histo-Tek®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name
Histo-Tek® FDA UDI
Generic Name
Histological tissue cassette biopsy insert IVD FDA UDI
Device Name
Biopsy Bags, Medium (4.5 x 6.5 cm); 500/box FDA UDI
Model / Reference
4221 FDA UDI
Description
Biopsy Bags, Medium (4.5 x 6.5 cm); 500/box FDA UDI

Identifiers

Catalog Number
4221 FDA UDI
Primary DI / UDI-DI
00615233007940 FDA UDI
FDA Product Code
NNK FDA UDI
GMDN Term
Histological tissue cassette biopsy insert IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Histological tissue cassette biopsy insert IVD

Histo-Tek® 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 b9af10eb-ab04-4898-af9d-6cb4260c3787 35 fields · synced May 31, 2026