Roberson
GUDID 00721902837951
PROSTHESIS 1133063 ROBERSON STAPES 1X4
MEDTRONIC XOMED, INC.
Ossicular prosthesis, partial| Primary Device ID | 00721902837951 |
| NIH Device Record Key | 182ae203-cd23-4d28-b0e5-1c3353639589 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Roberson |
| Version Model Number | 1133063 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 | 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 | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00721902837951 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K002897
FDA Product Code
| ETB | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-25 |
On-Brand Devices [Roberson]
| 00721902837968 | PROSTHESIS 1133064 ROBERSON STAPES 1X4.5 |
| 00721902837951 | PROSTHESIS 1133063 ROBERSON STAPES 1X4 |
| 00721902837944 | PROSTHESIS 1133062 ROBERSN STAPES .9X4.5 |
| 00721902837937 | PROSTHESIS 1133061 ROBERSON STAPES .9X4 |
| 00885074006666 | PROSTHESIS 1133066 ROBERSN STAPES 1X4.25 |
| 00885074006659 | PROSTHESIS 1133065 ROBERSON STPS .9X4.25 |
Trademark Results [Roberson]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROBERSON 73731296 1524864 Dead/Cancelled |
ROBERSON CORPORATION 1988-05-31 |
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