FDA UDI In Commercial Distribution 🇺🇸 United States

Essentials by 3D Dental

DI: 00817169022688 · Model: NGU300-M · 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
00817169022688
Version / Model
NGU300-M
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
2021-05-13
Public Version
1
Public Version Date
2021-05-21
Public Version Status
New
Public Device Record Key
cbaf8b2e-8398-4a74-ab2b-66f60b291e40

Device Description

Essentials Powder free Ultra Nitrile Exam Gloves Size M BOX/300

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LZC Patient Examination Glove, Specialty

GMDN Terms

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

Identifiers

Type ID
Package 10817169022685
Primary 00817169022688