OPTI-FIX 417492
GUDID 03596010124814
OPTI-FIX ACETABULAR DRILL GUIDE
Smith & Nephew, Inc.
Surgical drill guide, reusable| Primary Device ID | 03596010124814 |
| NIH Device Record Key | 93fdaac0-777f-4605-93c7-90d47414c1f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTI-FIX |
| Version Model Number | 417492 |
| Catalog Number | 417492 |
| 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)821-5700 |
| 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 | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03596010124814 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123598
FDA Product Code
| JDG | Prosthesis, hip, femoral component, cemented, metal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
[03596010124814]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2015-08-25 |
On-Brand Devices [OPTI-FIX]
| 00885556028858 | OPTIFIX 32 56-62 ANTVTD +4 TRIAL LINER |
| 00885556027448 | OPTIFIX 32 63-74 ANTVTD +4 TRIAL LINER |
| 00885556027424 | OPTIFIX 36 63-74 ANTVTD +4 TRIAL LINER |
| 00885556027226 | OPTIFIX 28 56-62 ANTVTD +4 TRIAL LINER |
| 00885556027042 | OPTIFIX 26 46-48 ANTVTD +4 TRIAL LINER |
| 00885556026946 | OPTIFIX 28 50-54 ANTVTD +4 TRIAL LINER |
| 00885556021910 | OPTIFIX XLPE ANTVTD 28 +4 50-54 |
| 00885556021637 | OPTIFIX XLPE ANTVTD 32 +4 63-74 |
| 00885556021590 | OPTI-FIX XLPE 28MM ID 20 DEGREE 63-74 OD LINER |
| 00885556021439 | OPTI-FIX XLPE 22MM ID 20 DEGREE 46-48 OD LINER |
| 00885556021231 | OPTIFIX XLPE ANTVTD 32 +4 56-62 |
| 00885556021026 | OPTI-FIX XLPE 22MM ID 20 DEGREE 44-45 OD LINER |
| 00885556021019 | OPTI-FIX XLPE 28MM ID 20 DEGREE 56-62 OD LINER |
| 00885556020913 | OPTIFIX XLPE ANTVTD 36 +4 63-74 |
| 00885556020388 | OPTI-FIX XLPE 26MM ID 20 DEGREE 50-54 OD LINER |
| 00885556020265 | OPTI-FIX XLPE 32MM ID 20 DEGREE 63-74 OD LINER |
| 00885556020043 | OPTIFIX XLPE ANTVTD 26 +4 46-48 |
| 00885556020036 | OPTIFIX XLPE ANTVTD 28 +4 56-62 |
| 00885556019955 | OPTI-FIX XLPE 26MM ID 20 DEGREE 46-48 OD LINER |
| 00885556019917 | OPTI-FIX XLPE 32MM ID 20 DEGREE 56-62 OD LINER |
| 03596010514059 | OPTI-FIX XLPE 28MM ID 20 DEGREE 50-54 OD LINER |
| 03596010124814 | OPTI-FIX ACETABULAR DRILL GUIDE |
Trademark Results [OPTI-FIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTI-FIX 76303713 2773948 Dead/Cancelled |
MITUTOYO AMERICA CORPORATION 2001-08-22 |
 OPTI-FIX 74387611 1821168 Live/Registered |
SMITH & NEPHEW, INC. 1993-05-04 |
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