FDA.reportPublic FDA data

n.a.

Primary DI
04048551378830
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
TL300
Device description
Cold Light Fountain Power LED 300
Published
2020-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NTNLed light source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551378830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551378830040485513788304048551378830

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

Regulatory Flags#

DUNS number
315731430
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851289007354FireflyFirefly GlobalNTN2025-07-18
00857556008642BR Surgical, LLCBR Surgical, LLCNTN2025-07-16
04580137732617MACHIDAMACHIDA ENDOSCOPE CO.,LTD.NTN2025-03-27
04250480100271NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100288NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100295NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100325NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100356NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100363NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
04048551317488n.aKarl Storz GmbH & Co. KGNTN2024-11-29
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
00840183528522BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183528539BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183500474BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00840183500023BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
06973031299894WhtNavi Light SourceGuangdong Optomedic Technologies, Inc.NTN2024-03-26
08033638801055Pen LEDSAPI MED SPANTN2023-08-02
04250369706747ILOILO electronic GmbHNTN2023-06-22
04250369706754ILOILO electronic GmbHNTN2023-06-22
04250369706761ILOILO electronic GmbHNTN2023-06-22
04250369706778ILOILO electronic GmbHNTN2023-06-22
04250369706785ILOILO electronic GmbHNTN2023-06-22
04250369706792ILOILO electronic GmbHNTN2023-06-22
04250369708352ILOILO electronic GmbHNTN2023-06-22
06971381250114LED Light SourceSCIVITA MEDICAL TECHNOLOGY CO., LTD.NTN2023-05-17
04049047657545NAGimmi GmbHNTN2023-05-03