FDA UDI Not in Commercial Distribution 🇺🇸 United States

CS 9300

DI: 60889978024186 · Model: CS 9300 · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
CS 9300
Primary DI
60889978024186
Version / Model
CS 9300
Catalog Number
8024184
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
633e2865-6d0b-4af0-a68f-85e0273ff489
Distribution End Date
2017-10-31

Device Description

CS 9300 CBCT Unit Only

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OAS X-ray, tomography, computed, dental

GMDN Terms

Code Name
61019 Cone beam computed tomography system, head/neck

Identifiers

Type ID
Primary 60889978024186