FDA UDI In Commercial Distribution 🇺🇸 United States

eZr™

DI: 00810038094441 · Model: FPZF020-1 · GARRISON DENTAL SOLUTIONS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
eZr™
Primary DI
00810038094441
Version / Model
FPZF020-1
Catalog Number
FPZF020-1
Company Name
GARRISON DENTAL SOLUTIONS, L.L.C.
Labeler DUNS
057647005
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-04-24
Public Version
2
Public Version Date
2020-07-07
Public Version Status
Update
Public Device Record Key
96174e9a-c669-4572-84dc-21851f7edb53

Device Description

Large Point Polisher, Fine Grit, Orange

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
Yes
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
EHL Point, Abrasive

GMDN Terms

Code Name
31833 Dental abrasive point, reusable

Identifiers

Type ID
Primary 00810038094441
Package 10810038094448
Package 20810038094445

Customer Contacts

Phone
888-437-0032