FDA UDI In Commercial Distribution 🇺🇸 United States

Acessa Pad Cable

DI: 00854763006119 · Model: 4300 · ACESSA HEALTH INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Acessa Pad Cable
Primary DI
00854763006119
Version / Model
4300
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
3
Public Version Date
2021-03-02
Public Version Status
Update
Public Device Record Key
8a8d6f87-9947-4a7c-9c56-533f2803cfe5

Device Description

Acessa Pad Cable, Reusable, connects to the Acessa ProVu Console Legacy DI #854763006072

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
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
OEW Tracking, Soft Tissue, Intraoperative
IYO System, Imaging, Pulsed Echo, Ultrasonic
HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

GMDN Terms

Code Name
57972 Radio-frequency ablation system

Identifiers

Type ID
Primary 00854763006119