Senhance

Primary DI
00815440021825
Brand
Senhance
Company
Asensus Surgical, Inc.
Model
X9007672
Device description
Senhance® Bipolar Atraumatic Grasper, Articulating (US)
Published
2023-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NAYSystem, Surgical, Computer Controlled Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAYSystem, Surgical, Computer Controlled InstrumentGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815440021825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815440021825008154400218258154400218250815440021825

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical telemanipulation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
969118900
Device count
1
DM exempt
false
Premarket exempt
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815440022624SenhanceX00171772026-03-09
00815440022266SenhanceX90077702025-01-14
00815440022273SenhanceX90077712025-01-14
00815440021924SenhanceX90076802023-09-19
00815440021856SenhanceX90076752023-08-17
00815440022235SenhanceX90077552023-08-17
00815440022242SenhanceX90077582023-08-17
00815440022259SenhanceX90077592023-08-17
00815440022280SenhanceX9007775X90077752022-07-11
00815440022228SenhanceX9007741X90077412021-02-19
00815440021931SenhanceX90076962020-08-05
00815440022075SenhanceX90077082020-08-05
00815440022082SenhanceX90077072020-08-05
00815440021122Senhance UltrasonicX9007618300-210112019-02-04
00815440021405SenhanceX9007034210-210112019-08-01
00815440021443SenhanceX9007306220-210122019-02-04
00815440021450SenhanceX9007309220-210102019-02-04
00815440021566Senhance UltrasonicX9007619300-110102019-02-04
00815440021573Senhance UltrasonicX9007620300-110112019-02-04
00815440021580Senhance UltrasonicX9007621300-010102019-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815440022624SenhanceAsensus Surgical, Inc.NAY2026-03-09
00886874123362da Vinci EnergyINTUITIVE SURGICAL, INC.NAY2025-08-14
00815440022266SenhanceAsensus Surgical, Inc.NAY2025-01-14
00815440022273SenhanceAsensus Surgical, Inc.NAY2025-01-14
00886874123447EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874123454EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874123461EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874124048EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874124055EndoWrist SPINTUITIVE SURGICAL, INC.NAY2024-12-09
00886874120736Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00886874120743Force FeedbackINTUITIVE SURGICAL, INC.NAY2024-03-21
00815440021924SenhanceAsensus Surgical, Inc.NAY2023-09-19
00815440021856SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022235SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022242SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022259SenhanceAsensus Surgical, Inc.NAY2023-08-17
00815440022280SenhanceAsensus Surgical, Inc.NAY2022-07-11
00886874121917SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121924SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121931SureformINTUITIVE SURGICAL, INC.NAY2022-05-11
00886874121474EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00886874121511EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00886874121528EndoWristINTUITIVE SURGICAL, INC.NAY2020-08-27
00815440021931SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022075SenhanceAsensus Surgical, Inc.NAY2020-08-05
00815440022082SenhanceAsensus Surgical, Inc.NAY2020-08-05
00886874119792EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874119808EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874120767EndoWristINTUITIVE SURGICAL, INC.NAY2020-05-07
00886874119136EndoWrist;daVinci SiINTUITIVE SURGICAL, INC.NAY2020-02-19