| Primary Device ID | 07613327623284 |
| NIH Device Record Key | 40d5a13c-e2b5-4ba8-aa69-389feb4be80d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Double Tier Tray Outer Shell |
| Version Model Number | 700002606011 |
| Catalog Number | 700002606011 |
| Company DUNS | 175239677 |
| Company Name | MAKO SURGICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 07613327623284 [Primary] |
| FMS | BED, PEDIATRIC OPEN HOSPITAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07613327623284]
Moist Heat or Steam Sterilization
[07613327623284]
Moist Heat or Steam Sterilization
[07613327623284]
Moist Heat or Steam Sterilization
[07613327623284]
Moist Heat or Steam Sterilization
[07613327623284]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2026-01-30 |
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| 07613327595567 - Robotic Arm Array Mount | 2026-02-09 |
| 07613327595772 - Shoulder irrigation Clip, Sterile | 2026-02-09 |
| 07613327623277 - Lower Tray, Mako Shoulder Tray | 2026-02-09 |
| 07613327623284 - Double Tier Tray Outer Shell | 2026-02-09 |
| 07613327623284 - Double Tier Tray Outer Shell | 2026-02-09 |
| 07613327625530 - MAKO Knee Tray Bottom Insert | 2026-02-09 |
| 07613327522006 - Mako | 2026-01-22 MICS 3 Handpiece |
| 07613327595505 - Mako Glenoid Retractor | 2026-01-16 |