TPLAN® Planning Station 109000
GUDID M9461090000
THINK SURGICAL, INC.
Stereotactic system application software| Primary Device ID | M9461090000 |
| NIH Device Record Key | 1ec6faaf-4511-4d3d-8498-abc215b79ba5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TPLAN® Planning Station |
| Version Model Number | 109000 |
| Catalog Number | 109000 |
| Company DUNS | 007211430 |
| Company Name | THINK 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M9461090000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230202
FDA Product Code
| OLO | Orthopedic stereotaxic instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-05 |
| Device Publish Date | 2023-08-28 |
Devices Manufactured by THINK SURGICAL, INC.
Trademark Results [TPLAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TPLAN 86081707 4760997 Live/Registered |
THINK SURGICAL, INC. 2013-10-03 |
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