FDA UDI In Commercial Distribution 🇺🇸 United States

Denovo Preformed Matrix Band

DI: 00810059291010 · Model: 170-405 · Denovo Dental, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Denovo Preformed Matrix Band
Primary DI
00810059291010
Version / Model
170-405
Company Name
Denovo Dental, Inc.
Labeler DUNS
183498179
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-30
Public Version
1
Public Version Date
2023-07-10
Public Version Status
New
Public Device Record Key
44e12a12-c295-49e4-be50-876e87d68c85

Device Description

Denovo Preformed Matrix Band - Adult 1/4, Size 5

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JEP Retainer, Matrix

GMDN Terms

Code Name
16195 Dental matrix band, reusable

Identifiers

Type ID
Primary 00810059291010