FDA.reportPublic FDA data

NA

Primary DI
04055207008393
Brand
NA
Company
Richard Wolf GmbH
Model
89141
Catalog number
89.141
Device description
SEALING CAP CAP 4-6MM large for instruments with diameter 4 to 6 mm, colour: red
Published
2024-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FJLResectoscope
GCMEndoscope, rigid
HIFInsufflator, laparoscopic
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJLResectoscopeGastroenterology, Urology2
GCMEndoscope, RigidGastroenterology, Urology2
HIFInsufflator, LaparoscopicObstetrics/Gynecology2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207008393PrimaryGS10
04055207069974Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207008393040552070083934055207008393
04055207069974040552070699744055207069974

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula seal, reusableA small, noninvasive device intended to be fitted into the proximal end of a laparoscopic access cannula to create a seal between the cannula and an introduced laparoscopic instrument, for inhibition of insufflation gas leakage. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
10
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
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
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421709CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421716CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
10845854045633AIRSEALConmed CorporationHIF2024-03-27
10845854045367CONMEDConmed CorporationHIF2023-12-04
09420012433978Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDHIF2023-07-06
10850082007186Filter AssemblyARMM INC.HIF2023-06-08
10850082007193Insufflator Filter AssemblyARMM INC.HIF2023-06-08
10850082007834Insufflator Filter AssemblyARMM INC.HIF2023-06-08
14026704912497WECKTELEFLEX INCORPORATEDHIF2023-02-24
14026704912503WECKTELEFLEX INCORPORATEDHIF2023-02-24
14042761085493OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085530OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085547OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085554OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085561OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085578OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085585OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085592OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085608OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085660OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085677OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
14042761085684OlympusOLYMPUS Winter & Ibe GmbHFJL2023-01-27
07613327147902NASTRYKER CORPORATIONHIF2022-12-08
07613327147971NASTRYKER CORPORATIONHIF2022-12-08
10851885004594AIRSEALConmed CorporationHIF2021-09-08
10845854051405AirSealConmed CorporationHIF2021-08-22
14042761085172OlympusOLYMPUS Winter & Ibe GmbHFJL2020-07-31
14042761085189OlympusOLYMPUS Winter & Ibe GmbHFJL2020-07-31