FDA UDI In Commercial Distribution 🇺🇸 United States

3D Dental

DI: 00817169024293 · Model: EN23 · 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
3D Dental
Primary DI
00817169024293
Version / Model
EN23
Catalog Number
EN23
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
2022-12-29
Public Version
1
Public Version Date
2023-01-06
Public Version Status
New
Public Device Record Key
0491929f-4f7f-474c-a0a9-d7426222aedb

Device Description

Endo Irrigation Needles 100/Pk 23ga

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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
DZM Needle, Dental

GMDN Terms

Code Name
12740 Dental syringe needle, single-use

Identifiers

Type ID
Primary 00817169024293