FDA.reportPublic FDA data

NA

Primary DI
04048551441800
Brand
NA
Company
Karl Storz GmbH & Co. KG
Model
TL410US
Catalog number
TL410US
Device description
POWER LED SAPHIRA, OPAL1 PDD
Published
2025-03-27
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551441800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551441800040485514418004048551441800

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and 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
+14242188201regulatory@karlstorz.com

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551161005n.a.408001102018-09-04
04048551291030NAV1408100202018-08-23
04048551325971n.a.408000212016-09-23
04048551160992n.a.408000902016-09-23
04048551277577n.a.408120202018-08-21
04048551325988n.a.408000512016-09-23
04048551336854NAV1408200202018-08-23
04048551337707n.a.408200862018-08-17
04048551337820NAV1408200302018-08-23
04048551271087n.a.408001202016-09-23
04048551387344n.a.408201232019-02-23
04048551387368n.a.408201502017-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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