FDA UDI In Commercial Distribution 🇺🇸 United States

Acessa ProVu Transducer with sensor

DI: 00854763006188 · Model: 7700 · ACESSA HEALTH INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Acessa ProVu Transducer with sensor
Primary DI
00854763006188
Version / Model
7700
Company Name
ACESSA HEALTH INC.
Labeler DUNS
080935394
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-10-11
Public Version
5
Public Version Date
2021-03-09
Public Version Status
Update
Public Device Record Key
e22717cb-b1ca-4ca1-83b1-d620b18a43f8

Device Description

Acessa ProVu Transducer with sensor, Reusable, connects to the Acessa ProVu Console

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
Yes
Sterilization Methods
Hydrogen Peroxide

Product Codes

Code Name
IYO System, Imaging, Pulsed Echo, Ultrasonic
OEW Tracking, Soft Tissue, Intraoperative
HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

GMDN Terms

Code Name
40770 Surgical ultrasound imaging transducer

Identifiers

Type ID
Primary 00854763006188