FDA UDI In Commercial Distribution 🇺🇸 United States

VISERA 4K UHD CAMERA CONTROL UNIT

DI: 04953170374630 · Model: OLYMPUS OTV-S400 · OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
6
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VISERA 4K UHD CAMERA CONTROL UNIT
Primary DI
04953170374630
Version / Model
OLYMPUS OTV-S400
Company Name
OLYMPUS MEDICAL SYSTEMS CORP.
Labeler DUNS
711789789
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
6
Public Version Date
2023-01-16
Public Version Status
Update
Public Device Record Key
62532145-ec52-4b88-9fd3-1e749d1003a6

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, general & plastic surgery
EOB NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
EOQ BRONCHOSCOPE (FLEXIBLE OR RIGID)
FGB Ureteroscope and accessories, flexible/rigid
NWB Endoscope, accessories, narrow band spectrum

GMDN Terms

Code Name
18034 Endoscopic video image processing unit

Identifiers

Type ID
Primary 04953170374630

Customer Contacts