FDA.reportPublic FDA data

Acessa ProVu System

Primary DI
15420045515307
Brand
Acessa ProVu System
Company
Hologic, Inc.
Model
7100
Catalog number
7100
Device description
The Acessa ProVu Console
Published
2023-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HFGCOAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045515307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551530715420045515307

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature-34 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045515260Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515277Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515291Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515246Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515253Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515314Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515284Acessa ProVu SystemHologic, Inc.HFG2022-11-08
00854763006256Acessa ProVu Dual Foot Pedal ACESSA HEALTH INC.HFG2020-12-07
14042761086278OlympusOLYMPUS Winter & Ibe GmbHHFG2020-07-31
00854763006102Acessa PadsACESSA HEALTH INC.HFG2018-10-11
00854763006119Acessa Pad CableACESSA HEALTH INC.HFG2018-10-11
00854763006126Acessa Table Top Field GeneratorACESSA HEALTH INC.HFG2018-10-11
00854763006140Acessa ProVu HandpieceACESSA HEALTH INC.HFG2018-10-11
00854763006157Acessa ProVu Handpiece CableACESSA HEALTH INC.HFG2018-10-11
00854763006188Acessa ProVu Transducer with sensorACESSA HEALTH INC.HFG2018-10-11
00854763006195Acessa ProVu Planar Field Generator (PFG)ACESSA HEALTH INC.HFG2018-10-11
00854763006232Acessa ProVu SystemACESSA HEALTH INC.HFG2018-10-11
00854763006249Acessa ProVu PFG Table ClampACESSA HEALTH INC.HFG2018-10-11
30653405009652CONMEDConmed CorporationHFG2016-09-24
30653405009669CONMEDConmed CorporationHFG2016-09-24
30653405009676CONMEDConmed CorporationHFG2016-09-24
30653405009683CONMEDConmed CorporationHFG2016-09-24
30653405009744CONMEDConmed CorporationHFG2016-09-24
30653405009768CONMEDConmed CorporationHFG2016-09-24
30653405009775CONMEDConmed CorporationHFG2016-09-24
30653405009782CONMEDConmed CorporationHFG2016-09-24
30653405009799CONMEDConmed CorporationHFG2016-09-24
30653405034449CONMEDConmed CorporationHFG2016-09-24
30653405034784NAConmed CorporationHFG2016-09-24
30653405034807CONMEDConmed CorporationHFG2016-09-24