FDA.reportPublic FDA data

n.a.

Primary DI
04048551082614
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27293BN
Device description
Operating Sheath, 26 Fr.
Published
2017-10-21
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

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
04048551082614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551082614040485510826144048551082614

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 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
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