FDA UDI In Commercial Distribution 🇺🇸 United States

VIDEO PROCESSOR

DI: 04961333244607 · Model: EPK-V1500C · PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VIDEO PROCESSOR
Primary DI
04961333244607
Version / Model
EPK-V1500C
Company Name
PENTAX OF AMERICA, INC.
Labeler DUNS
083211284
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-03-26
Public Version
3
Public Version Date
2020-05-19
Public Version Status
Update
Public Device Record Key
97c23b45-e54f-482d-a2f2-45ce9a6bffad

Device Description

VIDEO PROCESSOR - PTAH (VERSA) (USED)

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
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
PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement

GMDN Terms

Code Name
18034 Endoscopic video image processing unit

Identifiers

Type ID
Primary 04961333244607