FDA.report

NA

Primary DI
04055207038659
Brand
NA
Company
Richard Wolf GmbH
Model
89101
Catalog number
89.101
Device description
SEAL Ø 7.5MM silicone seal, yellow, for instruments 1-5mm, Length 2mm, reusable
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FGAKit, nephroscope
GCHMEDIASTINOSCOPE, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2
GCHMediastinoscope, DiagnosticGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207038659PrimaryGS10
04055207059616Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207038659040552070386594055207038659
04055207059616040552070596164055207059616

GMDN Terms

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.

Device Sizes

TypeValueUnit
Outer Diameter7.5Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810143891324Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891331Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891348Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891355Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891362Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891379Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891386Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891393Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
00810143891409Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
04055207069776NARichard Wolf GmbHFGA2024-04-01
00814334022825BOA VISIONRichard Wolf GmbHFGA2021-07-15
00814334022849COBRA VISIONRichard Wolf GmbHFGA2021-07-15
04250480106143NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-20
04250480106051NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106068NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106075NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106082NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106099NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106105NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106112NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106129NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106136NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106938NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-17
04250480106174NASCHÖLLY FIBEROPTIC GmbHFGA2020-04-16
04048551426654n.a.Karl Storz GmbH & Co. KGFGA2020-03-02
00851925007304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2020-02-10
00851925007359Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2020-02-10
50888439694473CARDINAL HEALTHCardinal Health 200, LLCFGA2020-01-24
00851925007274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2019-12-19
00851925007281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2019-12-19