FDA.reportPublic FDA data

Anovo Sterile Drape for Robotic Control Unit, bottom

Primary DI
07290018151136
Brand
Anovo Sterile Drape for Robotic Control Unit, bottom
Company
MOMENTIS SURGICAL LTD
Model
-
Catalog number
FP-04-0001
Device description
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit).There are two (2) sterile surgical drapes which separate the Anovo Robotic Control Units from the sterile field and maintains sterility – the Bottom Drape and Top Drape.Since the Robotic Control Units are fastened together, they are covered together as well.
Published
2021-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QNMMountable Electromechanical Surgical System For Transluminal Approaches

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNMMountable Electromechanical Surgical System For Transluminal ApproachesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018151133PackageGS110In Commercial Distribution
27290018151130PackageGS110In Commercial Distribution
07290018151136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001815113317290018151133
2729001815113027290018151130
07290018151136072900181511367290018151136

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
954-653-9210customerservice@momentissurgical.com

Regulatory Flags#

DUNS number
600482439
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018151331Anovo Instrument ARM Hook Electrode-FP-01-00042026-04-06
17290018151348Anovo Instrument ARM Curved Scissors-FP-01-00052026-04-06
07290018151310Anovo Robotic Control Unit20FP-02-00032025-03-11
07290018151303Anovo Surgeon Console20FP-03-00032025-03-11
07290018151297Anovo Pedestal1.00.000FP-05-00022025-03-25
17290018151355Anovo Pedestal1.00.000FP-05-00022025-03-25
07290018151037Anovo Power Cable-OS-04-00022021-10-07
07290018151112Anovo RCUSS Fixator-AS-04-00582021-10-07
07290018151129Anovo RCUSS Extension Rail-AS-04-00572021-10-07
07290018151143Anovo Sterile Drape for Robotic Control Unit, top-FP-04-00072021-10-07
07290018151167Anovo Cannula Obturator Needle-AS-04-00052021-10-07
07290018151181Anovo Mini Introducer-AS-04-00422021-10-07
07290018151204Anovo Vaginal Access Fixator-AS-04-00622021-10-07
07290018151211Anovo Cannula Short-MP-04-05472021-10-07
07290018151235Anovo ARMS Entry Guide -MP-04-05692021-10-07
07290018151242Anovo Cannula Long-MP-04-05482021-10-07
07290018151013Anovo Surgeon Console10FP-03-00032021-10-07
07290018151044Anovo Robotic Control Unit (RCU)-FP-02-00032021-10-07
07290018151051Anovo Unit Cable-FP-04-00042021-10-07
07290018151174Anovo Cannula Connector-AS-04-00362021-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17290018151331Anovo Instrument ARM Hook ElectrodeMOMENTIS SURGICAL LTDQNM2026-04-06
17290018151348Anovo Instrument ARM Curved ScissorsMOMENTIS SURGICAL LTDQNM2026-04-06
00836230005092Anovo MULTI-PORT STERILE DRAPEPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.QNM2026-03-15
07290018151297Anovo PedestalMOMENTIS SURGICAL LTDQNM2025-03-25
17290018151355Anovo PedestalMOMENTIS SURGICAL LTDQNM2025-03-25
07290018151310Anovo Robotic Control UnitMOMENTIS SURGICAL LTDQNM2025-03-11
07290018151303Anovo Surgeon ConsoleMOMENTIS SURGICAL LTDQNM2025-03-11
17290018151324Anovo Robotic Control UnitMOMENTIS SURGICAL LTDQNM2025-03-11
07290018151037Anovo Power CableMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151112Anovo RCUSS FixatorMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151129Anovo RCUSS Extension RailMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151143Anovo Sterile Drape for Robotic Control Unit, topMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151167Anovo Cannula Obturator NeedleMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151181Anovo Mini IntroducerMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151204Anovo Vaginal Access FixatorMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151211Anovo Cannula ShortMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151235Anovo ARMS Entry Guide MOMENTIS SURGICAL LTDQNM2021-10-07
07290018151242Anovo Cannula LongMOMENTIS SURGICAL LTDQNM2021-10-07
07290018151013Anovo Surgeon ConsoleMOMENTIS SURGICAL LTDQNM2021-10-07
17290018151034Hominis® Power CableMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
07290018151044Anovo Robotic Control Unit (RCU)MOMENTIS SURGICAL LTDQNM2021-10-07
07290018151051Anovo Unit CableMOMENTIS SURGICAL LTDQNM2021-10-07
17290018151119Hominis® RCUSS FixatorMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151126Hominis® RCUSS Extension RailMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151133HOMINIS® Sterile Drape for Robotic Control Unit, bottomMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151140Hominis® Sterile Drape for Robotic Control Unit, topMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
17290018151164Hominis® Cannula Obturator NeedleMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
07290018151174Anovo Cannula ConnectorMOMENTIS SURGICAL LTDQNM2021-10-07
17290018151188Hominis® Mini IntroducerMEMIC INNOVATIVE SURGERY LTDQNM2021-10-07
07290018151198Anovo Blunt Cannula ObturatorMOMENTIS SURGICAL LTDQNM2021-10-07