FDA.reportPublic FDA data

OTOPRONT

Primary DI
04260154546663
Brand
OTOPRONT
Company
Happersberger Otopront GmbH
Model
PES Pilot HDpro
Published
2023-07-04
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
FWCCamera, Television, Surgical, With Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWCCamera, Television, Surgical, With AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260154546663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260154546663042601545466634260154546663

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
315858175
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260154540234OTOPRONTPES Eco HD2024-12-02
04260154540241OTOPRONTPES Eco HD2024-12-02
04260154540258OTOPRONTSIT MAX one2024-12-02
04260154540012OTOPRONTSMART2023-07-04
04260154541002OTOPRONTBASIC PLUS2023-07-04
04260154541019OTOPRONTBASIC PLUS2023-07-04
04260154541026OTOPRONTBASIC PLUS2023-07-04
04260154541309OTOPRONTBASIC PLUS2023-07-04
04260154541606OTOPRONTBASIC PLUS2023-07-04
04260154546656OTOPRONTPES Pilot HDpro2023-07-04
04260154546731OTOPRONTOTOLUX-LED2023-07-04
04260154548100OTOPRONTSIT 42023-07-04
04260154548117OTOPRONTSIT 42023-07-04
04260154548209OTOPRONTSIT 4 PLUS2023-07-04
04260154548308OTOPRONTSIT 4 PLUS E2023-07-04
04260154548407OTOPRONTSIT 4 PLUS ER2023-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260154540234OTOPRONTHappersberger Otopront GmbHFWC2024-12-02
04260154540241OTOPRONTHappersberger Otopront GmbHFWC2024-12-02
00860008848925VoirElite 4K 31.5 Surgical DisplayJam-Labs Corp.FWC2024-01-15
04260154546656OTOPRONTHappersberger Otopront GmbHFWC2023-07-04
10381780356561Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2020-01-13
10381780356585Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFWC2020-01-13
10381780356608Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFWC2020-01-13
10381780356622Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2020-01-13
10381780356646Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2020-01-13
10381780509189Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2018-10-23
H8346009600Integra®INTEGRA LIFESCIENCES (IRELAND) LIMITEDFWC2018-10-23
M933MDF20010460Medical Facets NCMEDICAL FACETS NC LLCFWC2015-10-12