| Primary Device ID | 07611996111637 |
| NIH Device Record Key | df45c166-9bce-4270-b022-31ba875107a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIGALILEO |
| Version Model Number | 75018973 |
| Catalog Number | 75018973 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, 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 | true |
| OTC Over-The-Counter | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 07611996111637 [Primary] |
| HTY | PIN, FIXATION, SMOOTH |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
[07611996111637]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-11-25 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PIGALILEO 78162260 not registered Dead/Abandoned |
PI Precision Implants AG 2002-09-10 |