Steady Pro
GUDID 03665134000936
Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain the position of a transrectal ultrasound probe during ultrasound guided interventions.
KOELIS
Surgical instrument assist arm system, manually-adjusted| Primary Device ID | 03665134000936 |
| NIH Device Record Key | 5e2d42eb-6601-4338-8668-c4b3cc90644a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Steady Pro |
| Version Model Number | KSP.SUPP.TP2 |
| Company DUNS | 290318455 |
| Company Name | KOELIS |
| 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 | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com | |
| Phone | +33458176811 |
| qra@koelis.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03665134000912 [Primary] |
| GS1 | 03665134000936 [Package] Contains: 03665134000912 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171040
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
[03665134000936]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-11 |
| Device Publish Date | 2024-06-03 |
On-Brand Devices [Steady Pro]
| 03665134000592 | Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably m |
| 03665134000806 | Universal clamping base The steady pro range is intended to reliably maintain the position of a |
| 03665134000783 | Probe holder for transrectal approach |
| 03665134000745 | Probe holder for transperineal approach. The steady pro range is intended to reliably maintain t |
| 03665134000738 | Steady Pro Probe Holding Arm with I and U extension and rail clamping base The Steady Pro range |
| 03665134000936 | Probe holder for transperineal approach. The Steady Pro range is intended to reliably maintain t |
Trademark Results [Steady Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEADY PRO 75907426 not registered Dead/Abandoned |
Golf Systems, Inc. 2000-02-01 |
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