FDA UDI In Commercial Distribution 🇺🇸 United States

ENDOCAVITARY TRANSDUCER

DI: 04987670004285 · Model: PVT-681MVL · CANON MEDICAL SYSTEMS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ENDOCAVITARY TRANSDUCER
Primary DI
04987670004285
Version / Model
PVT-681MVL
Company Name
CANON MEDICAL SYSTEMS CORPORATION
Labeler DUNS
690575113
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-01
Public Version
3
Public Version Date
2018-07-06
Public Version Status
Update
Public Device Record Key
33e1b4c0-9071-490c-800b-8c7a4979d44f

Device Description

ENDOCAVITARY TRANSDUCER

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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ITX Transducer, ultrasonic, diagnostic

GMDN Terms

Code Name
40772 Rectal ultrasound imaging system transducer

Identifiers

Type ID
Primary 04987670004285

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K151451 000