Primary Device ID | 00815440022259 |
NIH Device Record Key | 6393067a-ba8e-4f81-9ac5-7d5abdd5f61d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Senhance |
Version Model Number | X9007759 |
Company DUNS | 969118900 |
Company Name | Asensus Surgical, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815440022259 [Primary] |
NAY | System, Surgical, Computer Controlled Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
[00815440022259]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-25 |
Device Publish Date | 2023-08-17 |
00815440022280 | Karl Storz 3D4K 10mm Endoscope Adapter |
00815440022259 | Articulating Instrument Coupler, Needle Driver |
00815440022242 | Articulating Instrument Coupler, Atraumatic Grasper |
00815440022235 | Articulating Instrument Adapter |
00815440021856 | Senhance® Needle Driver, Articulating (US) |
00815440021825 | Senhance® Bipolar Atraumatic Grasper, Articulating (US) |
00815440021924 | Olympus ENDOEYE 3D 10 mm Endoscope Adapter |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENHANCE 86953495 not registered Live/Pending |
Transenterix Surgical, Inc. 2016-03-25 |