FDA.reportPublic FDA data

Aura Elite

Primary DI
10858711006456
Brand
Aura Elite
Company
AMERICAN MEDICAL & DENTAL SUPPLIES INC
Model
DDS-502
Catalog number
DDS-502
Device description
Aura Elite DDS-502-20 Size Small - Box
Published
2023-01-19
Public version status
New
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
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858711006456PrimaryGS10
00858711006565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085871100645610858711006456
00858711006565008587110065658587110065650858711006565

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile 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 powder and it does not include antimicrobial agents/materials. 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 and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
018638145
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858711006176AuraPreneDDS-301DDS-3012023-02-01
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
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
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12