FDA.reportPublic FDA data

D-LIGHT C

Primary DI
04048551004654
Brand
D-LIGHT C
Company
Karl Storz GmbH & Co. KG
Model
20133620-134
Catalog number
20133620-134
Device description
Cold Light Fountain D-LIGHT C/US SCB
Published
2014-09-24
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
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
04048551004654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551004654040485510046544048551004654

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
424-218-8201su.chen@karlstorz.com
+14242188201regulatory@karlstorz.com

Regulatory Flags#

DUNS number
315731430
Device count
1
Combination product
true
Serial number
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
04048551402535n.a.Karl Storz GmbH & Co. KGOAY2018-05-30
04048551168639NAKarl Storz GmbH & Co. KGOAY2014-09-24
04048551064085TRICAM® Karl 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