FDA.reportPublic FDA data

NA

Primary DI
04055207011348
Brand
NA
Company
Richard Wolf GmbH
Model
885015
Catalog number
885015
Device description
ADAPTER FOR SEALING CAP 8931 CAP 15MM reusable
Published
2016-10-07
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
04055207011348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207011348040552070113484055207011348

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope assembly adaptorA connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.

Sterilization Methods#

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

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
true
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
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
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

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
04055207011324NARichard Wolf GmbHOTJ2016-09-30
04055207021071KEYPORTRichard Wolf GmbHOTJ2016-09-26
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