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Histoplex

FDA UDI

Class I (US FDA UDI)

by Pretium Canada Packaging ULC

Identity

Trade Name
Histoplex FDA UDI
Generic Name
General tissue specimen container IVD, no additive FDA UDI
Device Name
Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile. FDA UDI
Model / Reference
H602-FL FDA UDI
Description
Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile. FDA UDI

Identifiers

Primary DI / UDI-DI
10840165401062 FDA UDI
FDA Product Code
NNK FDA UDI
GMDN Term
General tissue specimen container IVD, no additive 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: General tissue specimen container IVD, no additive

Histoplex by Pretium Canada Packaging ULC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General tissue specimen container IVD, no additive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pretium Canada Packaging ULC

Sources (1)

  • FDA UDI 5e02c3e0-fa2b-4742-99a0-d62479ec52ec 33 fields · synced Jun 8, 2026