Profile 3D™
GUDID 00763000318505
SIZER SET 7680S PROFILE 3D 26L CE
MEDTRONIC, INC.
Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable| Primary Device ID | 00763000318505 |
| NIH Device Record Key | 60c688da-ea65-4112-aa4b-c241b1e1d1d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Profile 3D™ |
| Version Model Number | 7680S |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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 | false |
| 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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000318505 [Primary] |
FDA Product Code
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
[00763000318505]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-21 |
| Device Publish Date | 2023-11-13 |
On-Brand Devices [Profile 3D™]
| 00613994749437 | RING 680R36 PROFILE 3D 26L INSERT |
| 00613994749420 | RING 680R34 PROFILE 3D 26L INSERT |
| 00613994749413 | RING 680R32 PROFILE 3D 26L INSERT |
| 00613994749406 | RING 680R30 PROFILE 3D 26L INSERT |
| 00613994749390 | RING 680R28 PROFILE 3D 26L INSERT |
| 00613994749383 | RING 680R26 PROFILE 3D 26L INSERT |
| 00613994749376 | RING 680R24 PROFILE 3D 26L INSERT |
| 00613994410344 | RING 680R26 PROFILE 3D 26L |
| 00613994410337 | RING 680R32 PROFILE 3D 26L |
| 00613994410313 | RING 680R28 PROFILE 3D 26L |
| 00613994410306 | RING 680R30 PROFILE 3D 26L |
| 00613994410283 | RING 680R38 PROFILE 3D 26L |
| 00763000318505 | SIZER SET 7680S PROFILE 3D 26L CE |
Trademark Results [Profile 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFILE 3D 77107095 3473054 Live/Registered |
Medtronic, Inc. 2007-02-14 |
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