FDA.reportPublic FDA data

n.a.

Primary DI
04048551079409
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27074SZ
Catalog number
27074SZ
Device description
Adaptor
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
FBOCYSTOURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943668000KSEA CONTINOUS FLOW CYSTOSCOPEKARL STORZ Endoscopy-America, Inc.1994-09-21FBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551079409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551079409040485510794094048551079409

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel-opening adaptorA small device intended to be manually attached to an endoscope channel/port (e.g., air/water channel, venting port), or an endoscope channel-opening button, to keep the channel open during sterilization/disinfection, typically to allow the luminal flow of a gas/solution or for pressure equalization between the endoscope interior and exterior (sterilizer chamber) to prevent damage. 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
04048438000175NAKarl Storz GmbH & Co. KGFBO2025-03-27
04048551431382n.a.Karl Storz GmbH & Co. KGFBO2024-11-28
04953170438158Biopsy ValveOLYMPUS MEDICAL SYSTEMS CORP.FBO2023-04-22
04953170451980Luer-Split MAJ-2092OLYMPUS MEDICAL SYSTEMS CORP.FBO2022-08-05
04055207066218E-LINERichard Wolf GmbHFBO2020-02-21
04055207066225E-LINERichard Wolf GmbHFBO2020-02-21
04055207066195E-LINERichard Wolf GmbHFBO2020-02-21
04055207066201E-LINERichard Wolf GmbHFBO2020-02-21
04048551327746n.a.Karl Storz GmbH & Co. KGFBO2019-02-23
04048551390139n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390160n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390184n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390238n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390146n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390177n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
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00821925011229Elite IglesiasGyrus ACMI, LLCFBO2016-10-13
00821925008229USA Elite Gyrus ACMI, LLCFBO2016-10-05
00821925008243EliteGyrus ACMI, LLCFBO2016-10-05
00821925027275Gyrus ACMIGyrus ACMI, LLCFBO2016-10-05
04055207018385NARichard Wolf GmbHFBO2016-09-29
04055207018392NARichard Wolf GmbHFBO2016-09-29
04055207018491NARichard Wolf GmbHFBO2016-09-29
04055207018194MOXYRichard Wolf GmbHFBO2016-09-27
04055207018231GREENLIGHTRichard Wolf GmbHFBO2016-09-27
04055207018255GREENLIGHTRichard Wolf GmbHFBO2016-09-27