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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
Histology tissue cassette IVD, laboratory processing, single-use FDA UDI
Device Name
Standard with Lid Detached Blue FDA UDI
Model / Reference
9340 FDA UDI
Description
Standard with Lid Detached Blue FDA UDI

Identifiers

Catalog Number
9340 FDA UDI
Primary DI / UDI-DI
00615233082831 FDA UDI
FDA Product Code
IDZ FDA UDI
GMDN Term
Histology tissue cassette IVD, laboratory processing, single-use 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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Histology tissue cassette IVD, laboratory processing, single-use

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

Similar devices

Also classified as Histology tissue cassette IVD, laboratory processing, single-use.

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 4e3a59e4-de77-4f7e-b67e-5c844b34e5b8 35 fields · synced May 31, 2026