FDA.reportPublic FDA data

NA

Primary DI
04048551094754
Brand
NA
Company
Karl Storz GmbH & Co. KG
Model
26161UO
Device description
Obturator for 26161 U
Published
2014-09-24
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
HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)Obstetrics/Gynecologyf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551094754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551094754040485510947544048551094754

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"", ""Ethylene Oxide""]"

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
04048551051399NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551051405NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551051979NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551051993NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551052006NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551094716NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551094747NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551227046NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551227251NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551227299NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551230466NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551230473NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551230497NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551308325NAKarl Storz GmbH & Co. KGHFA2014-09-24
04048551091081HOPKINSKarl Storz GmbH & Co. KGHFA2014-09-24
04048551091128HOPKINSKarl Storz GmbH & Co. KGHFA2014-09-24
04048551091142HOPKINS Karl Storz GmbH & Co. KGHFA2014-09-24