FDA.reportPublic FDA data

Senhance

Primary DI
00815440022228
Brand
Senhance
Company
Asensus Surgical, Inc.
Model
X9007741
Catalog number
X9007741
Device description
Senhance Connect
Published
2021-02-19
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
FWGCamera, Television, Endoscopic, With Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWGCamera, Television, Endoscopic, With AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815440022228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815440022228008154400222288154400222280815440022228

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
969118900
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815440022266SenhanceX90077702025-01-14
00815440022273SenhanceX90077712025-01-14
00815440021924SenhanceX90076802023-09-19
00815440021825SenhanceX90076722023-08-17
00815440021856SenhanceX90076752023-08-17
00815440022235SenhanceX90077552023-08-17
00815440022242SenhanceX90077582023-08-17
00815440022259SenhanceX90077592023-08-17
00815440022280SenhanceX9007775X90077752022-07-11
00815440021931Senhance X9007696 2020-08-05
00815440022075SenhanceX90077082020-08-05
00815440022082Senhance X90077072020-08-05
00815440021122Senhance UltrasonicX9007618300-210112019-02-04
00815440021405SenhanceX9007034210-210112019-08-01
00815440021443SenhanceX9007306220-210122019-02-04
00815440021450SenhanceX9007309220-210102019-02-04
00815440021740SenhanceX9007649500-210172019-02-04
00815440021757SenhanceX9007660500-210162019-02-04
00815440021764SenhanceX9007661500-210152019-02-04
00815440021016SenhanceX9007221210-210142019-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
68051887046715THD Procto Software SystemTHD SPAFWG2025-02-20
04250365190717ATMOSATMOS MedizinTechnik GmbH & Co. KGFWG2024-11-27
68051887043295THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043301THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043318THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043325THD Procto Software SystemTHD SPAFWG2023-12-14
18033737712341THD Procto Software SystemTHD SPAFWG2022-10-07
58051887042642THD Procto Software SystemTHD SPAFWG2022-10-07
08033737713037THD Procto Software SystemTHD SPAFWG2021-07-19
18033737712389THD Procto Software SystemTHD SPAFWG2021-07-19
04961333242047N/APENTAX OF AMERICA, INC.FWG2018-03-08
04055207057469ENDOCAMRichard Wolf GmbHFWG2017-07-21
04961333231621n/aPENTAX OF AMERICA, INC.FWG2017-04-06
04055207055007NARichard Wolf GmbHFWG2016-09-23
04055207055014NARichard Wolf GmbHFWG2016-09-23