FDA.reportPublic FDA data

KEYPORT

Primary DI
04055207021071
Brand
KEYPORT
Company
Richard Wolf GmbH
Model
8850243
Catalog number
8850243
Device description
SILICONE SEALING INSERT with three valve accesses, PACK=3 PCS, with connection for CO2 insufflation / smoke aspiration, reusable
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTJLaparoscopic single port access device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTJLaparoscopic Single Port Access DeviceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207021071PrimaryGS10
04055207059517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207021071040552070210714055207021071
04055207059517040552070595174055207059517

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic multi-instrument access port, reusableA multi-lumen sleeve assembly intended to retract a small abdominal incision to allow multiple laparoscopic instruments to access the abdominal cavity simultaneously through a single abdominal incision, during minimally-invasive laparoscopic surgery. It will include a valve component for each lumen that maintains the established pneumoperitoneum; the trocar used to create the abdominal incision might be included; it may include attached external instrument holding arms. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
3
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29
04055207038529RIWO880288.022026-05-29
04055207038536RIWO880488.042026-05-29
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207007808NARichard Wolf GmbHOTJ2024-08-19
04055207069912NARichard Wolf GmbHOTJ2024-08-19
08719324463188symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
08719324463195symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
08719324463201symphonX™Fortimedix Surgical B.V.OTJ2019-05-22
04055207021088NARichard Wolf GmbHOTJ2018-09-24
08719324463171symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
08719324463003symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
08719324463072symphonX™Fortimedix Surgical B.V.OTJ2017-02-15
04055207011331NARichard Wolf GmbHOTJ2016-10-07
04055207011348NARichard Wolf GmbHOTJ2016-10-07
04055207011324NARichard Wolf GmbHOTJ2016-09-30
04055207011355KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011362KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011379KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207011386KEYPORTRichard Wolf GmbHOTJ2016-09-23
04055207021057NARichard Wolf GmbHOTJ2016-09-23
04055207021064NARichard Wolf GmbHOTJ2016-09-23
05391530440073TriPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440110QuadPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440066TriPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440097TriPort15ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13
05391530440103QuadPort+ADVANCED SURGICAL CONCEPTS LIMITEDOTJ2016-09-13