FDA.reportPublic FDA data

n.a.

Primary DI
04048551079621
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27085CR
Catalog number
27085CR
Device description
Cleaning Rod
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEOLithotriptor, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K843101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K843101000KARL STORZ 27086KC ULTRASONIC LITHOTRIKARL STORZ Endoscopy-America, Inc.1984-12-11FEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551079621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551079621040485510796214048551079621

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+14242188201regulatory@karlstorz.com

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
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
00821925044180SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044210SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044227SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044234SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044241SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043787SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043794SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043800SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043824SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus ACMI, LLCFEO2024-07-23
04953170026782Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-18
04953170318818Probe for LUS-2 2.0mm O.D.OLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-17
04953170026799Probe uncologging rodOLYMPUS MEDICAL SYSTEMS CORP.FEO2021-12-16
00821925043671ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043688ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043695ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043701ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043718ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925044203ShockPulseGyrus ACMI, LLCFEO2020-03-03
00821925043831ShockPulseGyrus ACMI, LLCFEO2020-03-02
00821925044197ShockPulseGyrus ACMI, LLCFEO2020-03-02
07613353125912LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2019-11-15
00821925039445Gyrus ACMIGyrus ACMI, LLCFEO2018-09-14
07613353156114LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2018-09-03