Pointe Scientific, Inc.

FDA UDI

by Pointe Scientific, Inc.

Identity

Trade Name: Pointe Scientific, Inc. FDA UDI
Generic Name: Medical device-decontamination agent FDA UDI
Device Name: System Cleaning Solution Kit for Hitachi analyzers. 1 x 500 ml FDA UDI
Model / Reference: HI790-SCS FDA UDI
Description: System Cleaning Solution Kit for Hitachi analyzers. 1 x 500 ml FDA UDI

Identifiers

Catalog Number: HI790-SCS FDA UDI
Primary DI / UDI-DI: 00811727012494 FDA UDI
GMDN Term: Medical device-decontamination agent FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Medical device-decontamination agent

Pointe Scientific, Inc. by Pointe Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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Manufacturer

Manufacturer: Pointe Scientific, Inc.

Sources (1)

FDA UDI 7f8aaead-5d28-4b08-a6b2-c1149db33cff 36 fields · synced Jun 1, 2026