FDA UDI In Commercial Distribution 🇺🇸 United States

QuickRay DX Size 1

DI: 00858475006269 · Model: 1 · DENTERPRISE INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
QuickRay DX Size 1
Primary DI
00858475006269
Version / Model
1
Catalog Number
02QDX20300
Company Name
DENTERPRISE INTERNATIONAL, INC.
Labeler DUNS
024913248
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-25
Public Version
1
Public Version Date
2023-08-02
Public Version Status
New
Public Device Record Key
c820a4d8-09e8-4249-9601-b984384d05f1

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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MUH System, X-Ray, Extraoral Source, Digital

GMDN Terms

Code Name
44905 Dental digital imaging sensor, intraoral

Identifiers

Type ID
Primary 00858475006269