Lower BayShield

FDA UDI

Class I (US FDA UDI)

by Northstar Medical Radioisotopes, Llc

Identity

Trade Name: Lower BayShield FDA UDI
Generic Name: Radiation shielding panel, fixed FDA UDI
Device Name: Optional lead shielding FDA UDI
Model / Reference: 40010624 FDA UDI
Description: Optional lead shielding FDA UDI

Identifiers

Catalog Number: 40010624 FDA UDI
Primary DI / UDI-DI: 00860002676418 FDA UDI
FDA Product Code: EAK FDA UDI
GMDN Term: Radiation shielding panel, fixed FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.6500 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiation shielding panel, fixed

Lower BayShield by Northstar Medical Radioisotopes, Llc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Northstar Medical Radioisotopes, Llc

Sources (1)

FDA UDI d081e6dd-c1be-4b1f-81e9-89883ebc62e2 34 fields · synced Jun 8, 2026