Standard Imaging HDR 1000 Plus

FDA UDI

Class II (US FDA UDI)

by Standard Imaging, Inc.

Identity

Trade Name: Standard Imaging HDR 1000 Plus FDA UDI
Generic Name: Radiation condenser R-meter FDA UDI
Device Name: Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for brachytherapy radiation QA measurements. FDA UDI
Model / Reference: 90008 FDA UDI
Description: Standard Imaging HDR 1000 Plus is a medical device intended as a transducer for brachytherapy radiation QA measurements. FDA UDI

Identifiers

Catalog Number: 90008 FDA UDI
Primary DI / UDI-DI: 00866562000212 FDA UDI
FDA Product Code: KPT FDA UDI
IWJ FDA UDI
JAQ FDA UDI
KXK FDA UDI
GMDN Term: Radiation condenser R-meter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1360 FDA UDI
892.5650 FDA UDI
892.5700 FDA UDI
892.5730 FDA UDI
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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiation condenser R-meter

Standard Imaging HDR 1000 Plus by Standard Imaging, Inc. — Class II — 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	Class II	Pending data

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Manufacturer

Manufacturer: Standard Imaging, Inc.

Sources (1)

FDA UDI d8c23809-6bf3-4bd0-bd40-37826870fa88 34 fields · synced Jun 8, 2026