FDA UDI In Commercial Distribution 🇺🇸 United States

FlexiStrips Regular Coarse/Medium

DI: D779501SMR1 · Model: 501CMR · COSMEDENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FlexiStrips Regular Coarse/Medium
Primary DI
D779501SMR1
Version / Model
501CMR
Company Name
COSMEDENT, INC.
Labeler DUNS
113911689
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-02-10
Public Version
3
Public Version Date
2020-05-06
Public Version Status
Update
Public Device Record Key
84fbe3c0-cf61-41e1-a71f-9b05d339c133

Device Characteristics

Single Use
Yes
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EHM Strip, Polishing Agent

GMDN Terms

Code Name
64617 Dental abrasive disk, single-use

Identifiers

Type ID
Primary D779501SMR1