Sleeve

FDA UDI

Class I (US FDA UDI)

by Burlington Medical, Llc

Identity

Trade Name: SLEEVE FDA UDI
Generic Name: Radiation shielding apron FDA UDI
Device Name: SLIP ON SLEEVES, .5MM STRATA 300, EXTRA LARGE FDA UDI
Model / Reference: SL33-R3SL3-XL FDA UDI
Description: SLIP ON SLEEVES, .5MM STRATA 300, EXTRA LARGE FDA UDI

Identifiers

Primary DI / UDI-DI: 00197513010890 FDA UDI
FDA Product Code: IWO FDA UDI
GMDN Term: Radiation shielding apron 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiation shielding apron

Sleeve by Burlington Medical, 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: Burlington Medical, Llc

Sources (1)

FDA UDI 13b5b5c8-9831-4f35-921d-60aa6990dd3f 33 fields · synced May 30, 2026