FDA.reportPublic FDA data

EndoGrab

Primary DI
M660EG000A0
Brand
EndoGrab
Company
VIRTUAL PORTS LTD
Model
EG000A
Catalog number
EG000A10
Device description
The EndoGrab intended purpose is to maneuver, manipulate, position, approximate, retract or anchor organs/ tissues, during traditional, robotic assisted and single port laparoscopic surgeries, allowing surgeons 3-dimensional organ movement and provide comprehensive maneuvering support during surgical procedure. The EndoGrab eliminates the need for a hand-held retractor during surgery.
Published
2024-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M660EG000A102PreviousHIBCC0
M660EG000A101PrimaryHIBCC0
M660EG000A0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Internally-anchored endoscopic retractorA sterile, nonimplantable, intraoperative surgical instrument designed to be inserted into the abdominal or thoracic cavity through a compatible endoscopic instrument (e.g., an access port) to provide hands-free retraction of a selected organ by anchoring it to the cavity wall during a surgical intervention (e.g., gastroenterological, gynaecological and urological laparoscopic or thoracoscopic procedures). It is inserted using a dedicated applier and typically consists of two interconnected clips that clutch the tissue for anchoring to the cavity wall and grasping the organ. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514870547
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M660EGS00A101EndoGrab-ShortEGS00AEGS00A102024-09-18
M660EGS00A0EndoGrab-ShortEGS00AEGS00A102024-09-18
M660EG000A101EndoGrabEG000AEG000A102024-03-01
M660EG000A102EndoGrabEG000AEG000A102021-06-23
M660EL000A52EndoLiftEL000AEL000A52021-06-23
M660AP030A0Applier 30cmAP030AAP030A2021-06-23
M660AP045A0Applier 45cmAP045AAP045A2021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27
00192896123663Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00192896123670Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00190776423902MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427443MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427450MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427467MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427474MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427481MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427498MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427504MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427511MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427528MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427535MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427658MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427702MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427719MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427726MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427818MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776420291MillenniumAvalign Technologies, Inc.GAD2026-08-25
G453FCE2004SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25
G453FCE2005SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25