PIGALILEO 75006787
GUDID 07611996099201
PLUS PIGALILEO NAV PIGALILEO MINI .ASSEM
Smith & Nephew, Inc.
Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system| Primary Device ID | 07611996099201 |
| NIH Device Record Key | 5afefbdd-7a9e-4daa-9b9d-63e150f3fa6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIGALILEO |
| Version Model Number | 75006787 |
| Catalog Number | 75006787 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, 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 | 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)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611996099201 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080875
FDA Product Code
| HAW | Neurological 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 | 2018-10-15 |
| Device Publish Date | 2018-09-13 |
On-Brand Devices [PIGALILEO]
| 07611996111637 | NAVIGATION PLATFORM PACKAGE SPEED-PINS 45MM WITH RIM |
| 07611996099201 | PLUS PIGALILEO NAV PIGALILEO MINI .ASSEM |
| 07611996099133 | PACKAGE SPEED-PINS 30MM RIM (6X) |
| 07611996079777 | PLUS PIGALILEO TKR DIST CUT UNIT MIS 1.2 |
| 07611996078145 | PIGALILEO TKR PATELLA CUTTING GUIDE MIS 1.27 |
| 07611996063196 | PLUS PIGALILEO TKR PLATE 6 DEG HIGH PLUS |
Trademark Results [PIGALILEO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIGALILEO 78162260 not registered Dead/Abandoned |
PI Precision Implants AG 2002-09-10 |
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