FDA.reportPublic FDA data

n.a.

Primary DI
04048551064313
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
20260030
Device description
Adapter for DCI Camera Heads
Published
2019-02-23
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
FWFCAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990154000KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMKarl Storz Imaging, Inc.1999-06-01FWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551064313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551064313040485510643134048551064313

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope camera adaptorAn optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00840319757987Hayden MedicalHayden Medical, Inc.FWF2026-04-23
00840319758984Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00840319758991Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-09-25
B366U1VI2512R01PROCAM HD BASICEclerisFWF2025-08-22
00840319757994Hayden MedicalHayden Medical, Inc.FWF2025-04-30
00840319757949Hayden MedicalHayden Medical, Inc.FWF2025-04-11
00840319757956Hayden MedicalHayden Medical, Inc.FWF2025-04-11
04048551061343NAKarl Storz GmbH & Co. KGFWF2025-03-28
08051887043286THD DIGITAL MINICAMTHD SPAFWF2025-02-20
18051887043283THD DIGITAL MINICAMTHD SPAFWF2025-02-20
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-01-09
00848657077071AED ENDOPRO 3DNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2025-01-08
04049197151634RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-10-16
04049197223270RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197223287RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197401654RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
04049197505604RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFWF2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-07-15
00848657076920ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-06-11
00848657076937ENDOPRO-MDTKNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FWF2024-06-11
00840319756966Hayden MedicalHayden Medical, Inc.FWF2024-04-12
04049047668640NAGimmi GmbHFWF2023-05-03
B366HC2202PROCAM EclerisFWF2023-04-04
04049047669692GimmiGimmi GmbHFWF2023-02-14
04250337100317C-Camsource®Joimax GmbHFWF2022-12-30
04250337100324C-Camsource®Joimax GmbHFWF2022-12-30
04250337100331C-Camsource®Joimax GmbHFWF2022-12-30
04250337100348C-Camsource®Joimax GmbHFWF2022-12-30
04250337100362D-Camsource®Joimax GmbHFWF2022-12-30