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RadQual

FDA UDI

Class I (US FDA UDI)

by Radqual, Llc

Identity

Trade Name
RadQual FDA UDI
Generic Name
Radionuclide source, quality assurance FDA UDI
Device Name
Co 60 "E" Vial FDA UDI
Model / Reference
BM06E-60 FDA UDI
Description
Co 60 "E" Vial FDA UDI

Identifiers

Primary DI / UDI-DI
00850020470211 FDA UDI
FDA Product Code
IXD FDA UDI
GMDN Term
Radionuclide source, quality assurance FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Radionuclide source, quality assurance

RadQual by Radqual, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radionuclide source, quality assurance.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radqual, Llc

Sources (1)

  • FDA UDI fa55d110-9add-4568-a345-c6dbc4834219 33 fields · synced Jun 6, 2026