FDA UDI Not in Commercial Distribution 🇺🇸 United States

TOTOKU

DI: 04996005103531 · Model: CCL550i2/F · JVC KENWOOD CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
TOTOKU
Primary DI
04996005103531
Version / Model
CCL550i2/F
Company Name
JVC KENWOOD CORPORATION
Labeler DUNS
713321040
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-01
Public Version
7
Public Version Date
2024-12-10
Public Version Status
Update
Public Device Record Key
ba427c0b-efff-4718-b7a2-e729eb0f1652
Distribution End Date
2018-11-30

Device Description

5MP Color LCD Monitor CL21550-B2F0U

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
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
PGY Display, Diagnostic Radiology

GMDN Terms

Code Name
36612 Image display unit, colour

Identifiers

Type ID
Primary 04996005103531

Premarket Submissions

Submission Number Supplement Number
K160326 000