FDA.reportPublic FDA data

n.a.

Primary DI
04048551002018
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
10384A
Device description
Cotton Carrier, 50 cm
Published
2018-09-04
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
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551002018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551002018040485510020184048551002018

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic sponge/swab forcepsA flexible manual device intended to be used in combination with a compatible endoscope (e.g., a gastroscope) to carry an absorbent pad of folded gauze or cotton into the site of intervention. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04250407721787FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721794FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721831FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721862FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721879FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721916FENTEXFENTEX medical GmbHLRC2022-12-09
04250407721923FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722036FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722043FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722050FENTEXFENTEX medical GmbHLRC2022-12-09
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04250407722395FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722401FENTEXFENTEX medical GmbHLRC2022-12-09
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04250407722425FENTEXFENTEX medical GmbHLRC2022-12-09
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04250407722456FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722463FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722470FENTEXFENTEX medical GmbHLRC2022-12-09
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04250407722500FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722517FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722524FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722531FENTEXFENTEX medical GmbHLRC2022-12-09
04250407722548FENTEXFENTEX medical GmbHLRC2022-12-09