AuraPrene DDS-305

GUDID 00858711006350

AuraPrene DDS-305 Size X-Large Inner Pack - 100

AMERICAN MEDICAL & DENTAL SUPPLIES INC

Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered
Primary Device ID00858711006350
NIH Device Record Key1eea52c5-7f7d-4743-b385-f311271937be
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuraPrene
Version Model NumberDDS-305
Catalog NumberDDS-305
Company DUNS018638145
Company NameAMERICAN MEDICAL & DENTAL SUPPLIES INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858711006350 [Primary]

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-09
Device Publish Date2023-02-01

On-Brand Devices [AuraPrene]

00858711006367AuraPrene DDS-303 Size Medium Inner Pack - 100
00858711006350AuraPrene DDS-305 Size X-Large Inner Pack - 100
00858711006336AuraPrene DDS-304 Size Large Inner Pack - 100
00858711006190AuraPrene DDS-301 Size Small Inner Pack - 100
00858711006176AuraPrene DDS-301 Size X-Small Inner Pack - 100

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