Hominis® Cannula Long

Primary DI
17290018151249
Brand
Hominis® Cannula Long
Company
MEMIC INNOVATIVE SURGERY LTD
Model
-
Catalog number
MP-04-0548
Device description
The Hominis® 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 Hominis Surgeon Console, two sterile instruments (Hominis Instrument ARMS®), bed-mounted Robotic Control Unit (RCU) and Hominis System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Vaginal Access Kit (UDI # 27290018151154) contains several accessories which facilitate insertion of the Hominis Instrument ARMS® transvaginally. The kit contains: Cannula Connector, Cannula (Short and long), Cannula Obturator Needle, ARMS Entry Guide, Blunt Cannula Obturator, Mini Introducer, Vaginal Access Fixator (includes attached Guiding Rail), Cannula Seal Extraction Tool and seals (Cannula Seal and ARMS Entry Guide Seal). The cannula sealed with a disposable seal (gasket) when inserted into the Applied Medical GelPoint Mini Access Platform.
Published
2021-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190022000Hominis Surgical SystemMomentis Surgical , Ltd.2021-02-26QNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018151249PackageGS11In Commercial Distribution
07290018151242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001815124917290018151249
07290018151242072900181512427290018151242

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, reusableA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable 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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
600482439
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018151034Hominis® Power Cable-OS-04-00022021-10-07
17290018151119Hominis® RCUSS Fixator-AS-04-00582021-10-07
17290018151126Hominis® RCUSS Extension Rail-AS-04-00572021-10-07
17290018151133HOMINIS® Sterile Drape for Robotic Control Unit, bottom-FP-04-00012021-10-07
17290018151140Hominis® Sterile Drape for Robotic Control Unit, top-FP-04-00072021-10-07
17290018151164Hominis® Cannula Obturator Needle-AS-04-00052021-10-07
17290018151188Hominis® Mini Introducer-AS-04-00422021-10-07
17290018151201Hominis® Vaginal Access Fixator-AS-04-00622021-10-07
17290018151218Hominis® Cannula Short-MP-04-05472021-10-07
17290018151232Hominis® ARMS Entry Guide -MP-04-05692021-10-07

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
07290018151136Anovo Sterile Drape for Robotic Control Unit, bottomMOMENTIS 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