FDA UDI In Commercial Distribution 🇺🇸 United States

FRESH Bold Impression Material

DI: 00815619021366 · Model: Liquid Putty Bulk · EXACTA DENTAL PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24

Basic Information

Brand Name
FRESH Bold Impression Material
Primary DI
00815619021366
Version / Model
Liquid Putty Bulk
Catalog Number
7495BK
Company Name
EXACTA DENTAL PRODUCTS INC
Labeler DUNS
016325552
Distribution Status
In Commercial Distribution
Device Count in Pkg
24
Record Status
Published
Publish Date
2016-09-16
Public Version
4
Public Version Date
2022-12-05
Public Version Status
Update
Public Device Record Key
72ee9a95-ce85-48e4-951c-9d5a3d8692da

Device Description

FRESH Bold Impression Material Liquid Putty Bulk

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ELW Material, Impression

GMDN Terms

Code Name
35866 Silicone dental impression material

Identifiers

Type ID
Primary 00815619021366
Unit of Use 00815619020581