Primary Device ID | 00848486016326 |
NIH Device Record Key | 55f49782-dd96-4964-a27d-cd875bc456b1 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 111695 |
Catalog Number | 111695 |
Company DUNS | 175239677 |
Company Name | MAKO SURGICAL CORP. |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 | 00848486016326 [Primary] |
OLO | Orthopedic stereotaxic instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-04-23 |
Device Publish Date | 2016-09-24 |
07613327599985 - Mako | 2023-07-31 |
07613327600001 - Mako | 2023-07-31 |
07613327600063 - Mako | 2023-07-31 |
07613327600070 - Mako | 2023-07-31 |
07613327601008 - Mako | 2023-07-31 |
00848486022747 - Calibration End Effector Inverted | 2022-10-13 Calibration End Effector Inverted |
07613327395341 - Mako | 2021-04-07 |
07613327395280 - NA | 2020-12-23 |