FDA UDI In Commercial Distribution 🇺🇸 United States

Aura Lotus

DI: 10858711006531 · Model: DDS-804 · AMERICAN MEDICAL & DENTAL SUPPLIES INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Aura Lotus
Primary DI
10858711006531
Version / Model
DDS-804
Catalog Number
DDS-804
Company Name
AMERICAN MEDICAL & DENTAL SUPPLIES INC
Labeler DUNS
018638145
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2023-01-19
Public Version
1
Public Version Date
2023-01-27
Public Version Status
New
Public Device Record Key
269be756-5411-4ce5-abf2-5d97e2d64552

Device Description

Aura Lotus DDS-804-20 Size Large -Box

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LZA Polymer Patient Examination Glove

GMDN Terms

Code Name
56286 Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Identifiers

Type ID
Unit of Use 00858711006565
Primary 10858711006531