FDA.reportPublic FDA data

NA

Primary DI
04055207023303
Brand
NA
Company
Richard Wolf GmbH
Model
8965141
Catalog number
8965.141
Device description
OBTURATOR FOR NEPHROSCOPE 24FR WL 229mm, round, cannulated, rounded distal end, compatible with sheath 8965041, reusable
Published
2021-03-03
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
FECOBTURATOR, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FECObturator, For EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207023303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207023303040552070233034055207023303

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope obturatorAn endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter8Millimeter

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
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
04250480106143NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-20
04250480106051NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106068NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106075NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106082NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106099NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106105NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106112NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106129NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106136NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106938NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-17
04250480106174NASCHÖLLY FIBEROPTIC GmbHFEC2020-04-16
00821925008168USA Elite Gyrus ACMI, LLCFEC2017-05-11
00821925003149USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925003156USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925003163USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925003170USA EliteGyrus ACMI, LLCFEC2016-10-14
00821925001480USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925001497USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925001503USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925001510USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002296USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002302USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925002326USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002333USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002371USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002388USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002401USA Elite Gyrus ACMI, LLCFEC2016-10-13
00821925002418USA EliteGyrus ACMI, LLCFEC2016-10-13
00821925002425USA Elite Gyrus ACMI, LLCFEC2016-10-13