FDA.report

Gimmi

Primary DI
04049047669692
Brand
Gimmi
Company
Gimmi GmbH
Model
S.2004.00 USB
Device description
ALPHANOVOCAM 4K UHD USB CAMERA SYSTEM INCL. CAMERA HEAD 4K 2160P
Published
2023-02-14
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

Related Records

Contact Domains

Product Codes

CodeName
FWFCamera, Television, Endoscopic, Without Audio

Product Code Classifications

CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049047669692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049047669692040490476696924049047669692

GMDN Terms

TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods

Method
Hydrogen Peroxide
Liquid Chemical

Contacts

PhoneEmail
+497461965900contact@gimmi.de

Regulatory Flags

DUNS number
316152610
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
true
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 DIBrandModelCatalogPublished
04049047788553GimmiCAM.1113.002026-03-04
04049047788577GimmiCAM.1113.902026-03-04
04049047788584GimmiCAM.1111.022026-03-04
04049047788607GimmiLIG.1110.002026-03-04
04049047783121GimmiS.2519.412025-12-03
04049047075295GimmiQO.1003.03QO.1003.032025-05-21
04049047075301GimmiQO.1003.04QO.1003.042025-05-21
04049047075318GimmiQO.1003.05QO.1003.052025-05-21
04049047075325GimmiQO.1003.06QO.1003.062025-05-21
04049047075332GimmiQO.1003.08QO.1003.082025-05-21
04049047075417GimmiQO.1005.04QO.1005.042025-05-21
04049047075424GimmiQO.1005.05QO.1005.052025-05-21
04049047075431GimmiQO.1005.06QO.1005.062025-05-21
04049047076452GimmiQO.1170.03QO.1170.032025-05-21
04049047076469GimmiQO.1170.04QO.1170.042025-05-21
04049047076612GimmiQO.1173.03QO.1173.032025-05-21
04049047077077GimmiQO.1430.08QO.1430.082025-05-21
04049047077084GimmiQO.1430.14QO.1430.142025-05-21
04049047078005GimmiQO.2050.04QO.2050.042025-05-21
04049047078043GimmiQO.2052.02QO.2052.022025-05-21

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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
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
04260744830561Fibre optic cableJoimax GmbHFWF2022-12-30
04260744831865Fibre optic cableJoimax GmbHFWF2022-12-30
B366U1HC112G22 PROCAM HD BASICEclerisFWF2022-09-07
B366U1VI2512PROCAM HD BASICEclerisFWF2022-09-07
B366HC2201PROCAM EclerisFWF2022-08-03
B366U1VI2511PROCAM Basic PALEclerisFWF2022-06-30
B366U1VI3111PROCAM FULL PALEclerisFWF2022-06-30
B366HC220PROCAM SDEclerisFWF2022-06-27
B366U1HC112G21 PROCAM SDEclerisFWF2022-06-27
10845854030059NAConmed CorporationFWF2021-12-15