FDA.reportPublic FDA data

AuraPrene

Primary DI
00858711006176
Brand
AuraPrene
Company
AMERICAN MEDICAL & DENTAL SUPPLIES INC
Model
DDS-301
Catalog number
DDS-301
Device description
AuraPrene DDS-301 Size X-Small Inner Pack - 100
Published
2023-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858711006176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858711006176008587110061768587110061760858711006176

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA non-sterile device made of polychloroprene (neoprene) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
018638145
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858711006190AuraPreneDDS-302DDS-3022023-02-01
00858711006336AuraPreneDDS-304DDS-3042023-02-01
00858711006350AuraPreneDDS-305DDS-3052023-02-01
00858711006367AuraPreneDDS-303DDS-3032023-02-01
10858711006395Aura TouchDDS-102DDS-1022023-01-19
10858711006401Aura TouchDDS-103DDS-1032023-01-19
10858711006418Aura TouchDDS-104DDS-1042023-01-19
10858711006449Aura EliteDDS-501DDS-5012023-01-19
10858711006456Aura EliteDDS-502DDS-5022023-01-19
10858711006463Aura EliteDDS-503DDS-5032023-01-19
10858711006470Aura EliteDDS-504DDS-5042023-01-19
10858711006487Aura EliteDDS-505DDS-5052023-01-19
10858711006500Aura LotusDDS-801DDS-8012023-01-19
10858711006517Aura LotusDDS-802DDS-8022023-01-19
10858711006524Aura LotusDDS-803DDS-8032023-01-19
10858711006531Aura LotusDDS-804DDS-8042023-01-19
10858711006548Aura LotusDDS-805DDS-8052023-01-19
10858711006586Aura 300DDS-403DDS-4032023-01-19
10858711006593Aura 300DDS-404DDS-4042023-01-19
10858711006609Aura 300DDS-405DDS-4052023-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZA2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZA2026-10-07
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
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00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
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00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18