FDA.reportPublic FDA data

n.a.

Primary DI
04048551396049
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
8403XDP
Device description
Connecting Cable
Published
2019-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551396049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551396049040485513960494048551396049

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method
Ethylene Oxide;Hydrogen Peroxide;High-level Disinfectant;Peracetic Acid

Contacts#

Phone, Email table
PhoneEmail
+14242188201regulatory@karlstorz.com

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
true
Serial number
false
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
true

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
00198506089633ELMED INCORPORATEDELMED INCORPORATEDCCW2026-03-17
06974525071507Video LaryngoscopeShenzhen Zhixin Biomedical Technology Co., Ltd.CCW2026-02-04
00198506088063ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-22
00198506087868ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087875ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087882ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087905ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
05707480164264Ambu® SureSight® Data CableAmbu A/SCCW2025-12-19
05707480164301Ambu® SureSight® Battery ChargerAmbu A/SCCW2025-12-19
09348811110183INKAThe Trustee for KAISER FAMILY TRUSTCCW2025-11-25
10884521849761McGRATH MAC+Covidien LPCCW2025-11-17
00198506085727ELMED INCORPORATEDELMED INCORPORATEDCCW2025-09-19
04250676716095Surgical laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-19
04250381858431Laser laryngoscope, size 1, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858448Laser laryngoscope, size 2, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858455Laser laryngoscope, size 3, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858462Laser laryngoscope, size 4, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858479Laser laryngoscope, size 5, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858486Laser laryngoscope, size 6, black, forSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858493Laser laryngoscope, size 7, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676739933Holinger laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741646Laser laryngoscope, Ulm typeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741660Smoke evacuation tubeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
00840183530662BR Surgical, LLCBR Surgical, LLCCCW2025-08-21
20197344135667MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135834MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135919MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135933MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135964MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135971MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14