K102

GUDID 00840331298482

K102, TAILORED/CUSTOM/STANDARD, .25MM XENOLITE STRATA 500

BURLINGTON MEDICAL, LLC

Radiation shielding apron
Primary Device ID00840331298482
NIH Device Record Key9432058d-49e7-413a-a52d-edda4bb9fb46
Commercial Distribution StatusIn Commercial Distribution
Brand NameK102
Version Model NumberU5K102
Company DUNS083381202
Company NameBURLINGTON MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840331298482 [Primary]

FDA Product Code

IWOApron, Protective

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-12
Device Publish Date2024-08-02

On-Brand Devices [K102]

00840331298505K102, TAILORED/CUSTOM/STANDARD, .5MM XENOLITE STRATA 500
00840331298499K102, TAILORED/CUSTOM/STANDARD, .35MM XENOLITE STRATA 500
00840331298482K102, TAILORED/CUSTOM/STANDARD, .25MM XENOLITE STRATA 500

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