FDA UDI Not in Commercial Distribution 🇺🇸 United States

ClearProbe

DI: B377GMD61ENDUS40 · Model: Endocavity V4 · GLOBALMEDIA GROUP, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ClearProbe
Primary DI
B377GMD61ENDUS40
Version / Model
Endocavity V4
Catalog Number
GMD61ENDUS4
Company Name
GLOBALMEDIA GROUP, LLC
Labeler DUNS
103201849
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-06
Public Version
4
Public Version Date
2023-08-11
Public Version Status
Update
Public Device Record Key
7f7d4aa3-02b4-497e-a86a-2e71c70c5c4b
Distribution End Date
2023-08-10

Device Description

USB ultrasound probe, general purpose/endocavity.

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
ITX Transducer, Ultrasonic, Diagnostic
IYO System, Imaging, Pulsed Echo, Ultrasonic

GMDN Terms

Code Name
40768 Extracorporeal ultrasound imaging transducer, hand-held

Identifiers

Type ID
Primary B377GMD61ENDUS40