FDA.reportPublic FDA data

n.a.

Primary DI
04048551057322
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
146001
Device description
Eustachian Catheter, size 1, 13.5 cm
Published
2019-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KCLBLOWER, POWDER, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCLBlower, Powder, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551057322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551057322040485510573224048551057322

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, reusableA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
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
00840183527938BR Surgical, LLCBR Surgical, LLCKCL2024-10-18
00840183512088BR Surgical, LLCBR Surgical, LLCKCL2024-06-03
00840183520021BR Surgical, LLCBR Surgical, LLCKCL2024-06-03
05060259073021DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCL2023-10-05
25060259073025DryswabMEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITEDKCL2023-10-05
04048551057278n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057285n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057339n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057353n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057315n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057469n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
04048551057476n.a.Karl Storz GmbH & Co. KGKCL2019-02-23
00850000126053SHEEHY-HOUSE POWDER INSUFFLATOROto-Med, Inc.KCL2018-09-21
00192896039322KABIERSKE POWDER BLOWER SETSONTEC INSTRUMENTS, INC.KCL2018-09-17
00192896039339KABIERSKE POWDER BLOWER CANNULASONTEC INSTRUMENTS, INC.KCL2018-09-12
04048551057292n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057308n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057360n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057377n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057384n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057391n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057346n.a.Karl Storz GmbH & Co. KGKCL2018-09-04
04048551057445n.a.Karl Storz GmbH & Co. KGKCL2018-09-04