n.a.

Primary DI
04048551402535
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
11272VNIUA
Device description
Flexible Video Urethro-Cystoscope, PDD
Published
2018-05-30
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
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
04048551402535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551402535040485514025354048551402535

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystourethroscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. It is used for biopsy, removal of small stones, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Peracetic Acid"", ""Ethylene Oxide"", ""Hydrogen Peroxide"", ""High-level Disinfectant""]"
Peracetic Acid;Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
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
04048551423516n.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
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