FDA UDI In Commercial Distribution 🇺🇸 United States

Acessa ProVu System

DI: 15420045515307 · Model: 7100 · Hologic, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Acessa ProVu System
Primary DI
15420045515307
Version / Model
7100
Catalog Number
7100
Company Name
Hologic, Inc.
Labeler DUNS
018925968
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-05-16
Public Version
1
Public Version Date
2023-05-24
Public Version Status
New
Public Device Record Key
4c2f43c5-6c10-4f9a-95ac-3bf1c5c7666b

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
Yes
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
HFG COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

GMDN Terms

Code Name
57972 Radio-frequency ablation system

Identifiers

Type ID
Primary 15420045515307

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-34 – 65 Degrees Celsius
Type
Handling Environment Temperature
Temperature Range
10 – 30 Degrees Celsius