FDA.reportPublic FDA data

n.a.

Primary DI
04048551074213
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27026DO
Device description
Obturator, for 27026D/DB, 27027D/DN
Published
2016-09-23
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
04048551074213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551074213040485510742134048551074213

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope obturatorAn endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. 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
04048551231562n.a.Karl Storz GmbH & Co. KGODB2018-07-21
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
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