FDA.reportPublic FDA data

NA

Primary DI
04055207008607
Brand
NA
Company
Richard Wolf GmbH
Model
163905
Catalog number
163.905
Device description
ADAPTER for leakage test in OLYMPUS endoscope washer-disinfector machines
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
FAJCystoscope and accessories, flexible/rigid
FBNCholedochoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207008607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207008607040552070086074055207008607

GMDN Terms#

Term, Definition table
TermDefinition
Invasive medical device leak tester, mechanicalA hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.

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
1
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
04055207066805NARichard Wolf GmbHFBN2026-06-02
04055207007709NARichard Wolf GmbHFBN2026-05-29
04055207007723RIWORichard Wolf GmbHFBN2026-05-29
04055207007747NARichard Wolf GmbHFBN2026-05-29
04055207007792NARichard Wolf GmbHFBN2026-05-29
04055207007815NARichard Wolf GmbHFBN2026-05-29
04055207007839NARichard Wolf GmbHFBN2026-05-29
04055207008409NARichard Wolf GmbHFBN2026-05-29
04055207038505RIWORichard Wolf GmbHFBN2026-05-29
04055207038529RIWORichard Wolf GmbHFBN2026-05-29
04055207038536RIWORichard Wolf GmbHFBN2026-05-29
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850061601001Tangent Digital catheterTangent Endoscopy LLCFBN2026-04-08
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
00850023925237WiScope®Otu Medical Inc.FBN2023-04-30
00850023925244WiScope®Otu Medical Inc.FBN2023-04-30
00850023925251WiScope®Otu Medical Inc.FBN2023-04-30
00850023925268WiScope®Otu Medical Inc.FBN2023-04-30
00850023925299WiScope®Otu Medical Inc.FBN2023-04-30
00850023925305WiScope®Otu Medical Inc.FBN2023-04-30