FDA.reportPublic FDA data

n.a.

Primary DI
04048551102527
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
26183MB
Device description
SUPRALOOP Outer Sheath, 5 mm, 30 cm
Published
2018-07-21
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
KNFCOAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551102527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551102527040485511025274048551102527

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, reusableA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05708265016365LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
10817929020364Sonata® Dispersive ElectrodeGynesonics, Inc.KNF2021-07-07
30817929020177Sonata® RFA Handpiece Cable, ReusableGynesonics, Inc.KNF2021-07-07
14042761086254OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
14042761086278OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
00810116021666Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021673Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021680Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021642Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
00810116021659Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
10817929020241Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
10817929020142Sonata® IUUS Probe Soaking CylinderGynesonics, Inc.KNF2019-05-10
10817929020180Sonata® System Cart Gynesonics, Inc.KNF2019-05-10
10817929020197Sonata® SMART TabletGynesonics, Inc.KNF2019-05-10
10817929020203Sonata® System Radiofrequency GeneratorGynesonics, Inc.KNF2019-05-10
10817929020326Sonata® Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc.KNF2019-05-10
30817929020092Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
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00817428020721ModulapATC TECHNOLOGIES, INC.KNF2016-09-24
04046963682262AESCULAPAesculap AGKNF2016-09-24
20653405035067CONMEDConmed CorporationKNF2016-09-24