FDA.reportPublic FDA data

n.a.

Primary DI
04048551231562
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27026A
Device description
Cystoscope Sheath, 25 Fr.
Published
2018-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ODBendoscopic contamination prevention sheath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODBEndoscopic Contamination Prevention SheathGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551231562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551231562040485512315624048551231562

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009064706Transport Endoscopic Access DeviceUsgi Medical, Inc.ODB2022-12-20
00860009064751Transport Endoscopic Access DeviceUsgi Medical, Inc.ODB2022-12-20
08714729974604ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974611ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974628ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974635ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
08714729974642ORISE™BOSTON SCIENTIFIC CORPORATIONODB2018-03-05
04048551016695n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074114n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074138n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074152n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074176n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074190n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074213n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074237n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074251n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074336n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074374n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074411n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074459n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074480n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074497n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074510n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074541n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074664n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074688n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074701n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074725n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074763n.a.Karl Storz GmbH & Co. KGODB2016-09-23
04048551074787n.a.Karl Storz GmbH & Co. KGODB2016-09-23