FDA UDI In Commercial Distribution 🇺🇸 United States

RealCloud HD1

DI: 00864058000326 · Model: 1 · REALCLOUD IMAGING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RealCloud HD1
Primary DI
00864058000326
Version / Model
1
Company Name
REALCLOUD IMAGING, INC.
Labeler DUNS
079879515
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-12-20
Public Version
1
Public Version Date
2019-01-21
Public Version Status
New
Public Device Record Key
3a5eb0eb-ddf1-4e12-94fa-5dac596e99f1

Device Description

HDTV intraoral camera

Device Characteristics

Single Use
No
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
Yes
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
NRD Unit, Operative Dental, Accessories

GMDN Terms

Code Name
63672 Intraoral camera

Identifiers

Type ID
Primary 00864058000326