FDA.reportPublic FDA data

n.a.

Primary DI
04048551272268
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
11577A
Device description
Mini Straight Forward Telescope 0°, 1 mm
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
EIAUNIT, OPERATIVE DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551272268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551272268040485512722684048551272268

GMDN Terms#

Term, Definition table
TermDefinition
SialendoscopeAn endoscope with a slender semiflexible inserted portion intended for the visual examination and treatment of the salivary ducts. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in combination with special instruments (e.g., forceps, laser probes, stone extractors) to locate and extract/treat a salivary stone (sialolithiasis) and/or a stricture (sialostenosis) in the submandibular, parotid, and/or sublingual salivary duct. This is a reusable device intended to be sterilized before use.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Liquid Chemical"", ""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Liquid Chemical;Hydrogen Peroxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
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

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