FDA UDI In Commercial Distribution 🇺🇸 United States

Essentials by 3D Dental

DI: 00817169029809 · Model: LG100-XL · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Essentials by 3D Dental
Primary DI
00817169029809
Version / Model
LG100-XL
Catalog Number
LG100-XL
Company Name
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Labeler DUNS
080194935
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-10-17
Public Version
1
Public Version Date
2023-10-25
Public Version Status
New
Public Device Record Key
842864eb-5202-4dc9-8447-a0d02ecbb603

Device Description

Essentials Powder free Latex Exam Gloves Size X-Large Box of 100

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
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LYY Latex Patient Examination Glove

GMDN Terms

Code Name
47172 Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Identifiers

Type ID
Package 10817169029806
Primary 00817169029809