FDA.reportPublic FDA data

BOA VISION

Primary DI
00814334022825
Brand
BOA VISION
Company
Richard Wolf GmbH
Model
7355071US
Catalog number
7355071US
Device description
SENSOR-URETERORENOSCOPE 8.7FR WL 680MM
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGAKit, nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814334022825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814334022825008143340228258143340228250814334022825

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video ureterorenoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length680Millimeter
Outer Diameter2.9Millimeter

Sterilization Methods#

Method table
Method
Hydrogen Peroxide

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DI, Brand, Model table
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 DI, Brand, Company table
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
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
00851925007298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2019-12-19