FDA UDI In Commercial Distribution 🇺🇸 United States

CTCD

DI: 08800204900029 · Model: CTUD-C103 · CTCELLS, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
CTCD
Primary DI
08800204900029
Version / Model
CTUD-C103
Company Name
CTCELLS, Inc.
Labeler DUNS
963366615
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-03-19
Public Version
1
Public Version Date
2025-03-27
Public Version Status
New
Public Device Record Key
cb961119-3e19-40d4-8acb-0bac2f727a0b

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
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
GKH Apparatus, Automated Blood Cell Diluting

GMDN Terms

Code Name
66504 Circulating tumour cell separation system cassette IVD

Identifiers

Type ID
Primary 08800204900029