FDA UDI In Commercial Distribution 🇺🇸 United States

Prevue Try-In Kit

DI: D7796040053 · Model: 604005 · COSMEDENT, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Prevue Try-In Kit
Primary DI
D7796040053
Version / Model
604005
Catalog Number
604005
Company Name
COSMEDENT, INC.
Labeler DUNS
113911689
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-22
Public Version
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
834bb6b5-017b-4716-ab4b-2d108e1d9d00

Device Description

Prevue Try-In Kit includes 7 (2.5 g) Prevue Try-In syringes, 2 Cosmedent brushes (#1 and #3),and Syringe Tips (20 pack-19 gauge).

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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

GMDN Terms

Code Name
61482 Dental cement trial

Identifiers

Type ID
Primary D7796040053