FDA.reportPublic FDA data

n.a.

Primary DI
04048551423516
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
27100MV
Device description
Suction Valve, for Cystoscopes
Published
2020-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OAYLight source system, diagnostic endoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAYLight Source System, Diagnostic EndoscopicUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P050027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050027000KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEMKARL STORZ Endoscopy-America, Inc.2010-05-28OAY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551423516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551423516040485514235164048551423516

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, reusableA non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551441800NAKarl Storz GmbH & Co. KGOAY2025-03-27
04048551423530n.a.Karl Storz GmbH & Co. KGOAY2020-03-02
04048551423547n.a.Karl Storz GmbH & Co. KGOAY2020-03-02
04048551063910n.a.Karl Storz GmbH & Co. KGOAY2018-08-21
04048551402528n.a.Karl Storz GmbH & Co. KGOAY2018-05-30
04048551402535n.a.Karl Storz GmbH & Co. KGOAY2018-05-30
04048551168639NAKarl Storz GmbH & Co. KGOAY2014-09-24
04048551064085TRICAM® Karl Storz GmbH & Co. KGOAY2014-09-24
04048551004654D-LIGHT CKarl Storz GmbH & Co. KGOAY2014-09-24
04048551064092TRICAM® Karl Storz GmbH & Co. KGOAY2014-09-24
04048551064160TRICAM® Karl Storz GmbH & Co. KGOAY2014-09-24
04048551073094HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551073131HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551073209HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551289532HOPKINS Karl Storz GmbH & Co. KGOAY2014-09-24
04048551350652TRICAM® Karl Storz GmbH & Co. KGOAY2014-09-24