FDA.report

n.a.

Primary DI
04048551079812
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27090AG
Device description
Guide wire, rigid
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FGAKit, nephroscope

Product Code Classifications

CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048551079812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048551079812040485510798124048551079812

GMDN Terms

TermDefinition
Urethral bougie, reusableA rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

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