Intertan E0018152-1
GUDID 00885556911891
PITCHFORK HANDLE FOR TRIAL INSERTS
Smith & Nephew, Inc.
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00885556911891 |
| NIH Device Record Key | af3b178a-e988-4bde-8383-e0c447d10445 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intertan |
| Version Model Number | E0018152-1 |
| Catalog Number | E0018152-1 |
| Company DUNS | 045483575 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556911891 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111711
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
[00885556911891]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-26 |
| Device Publish Date | 2023-09-18 |
On-Brand Devices [Intertan]
| 00885556738627 | INTERTAN ENTRY TUBE |
| 00885556738610 | INTERTAN 16MM CHANNEL REAMER |
| 00885556733578 | SWIVEL GUIDE BOLT WRENCH |
| 00885556719916 | DOUBLE LENGTH OBTURATOR |
| 00885556686942 | LAG SCREW DRIVER W/ HALL-JACOBS ADAPTER |
| 00885556666821 | SWIVEL GUIDE BOLT WRENCH |
| 00885556666814 | LONG 12.5MM ENTRY REAMER |
| 00885556666807 | LONG 16MM ENTRY REAMER |
| 00885556666791 | LONG ENTRY TUBE |
| 00885556666784 | 343MM DIRECT MEASURING GAGE |
| 00885556662366 | SWIVEL GUIDE BOLT WRENCH |
| 00885556648742 | DOUBLE LENGTH OBTURATOR |
| 00885556648735 | DOUBLE LENGTH OBTURATOR |
| 00885556389447 | COMPRESSION SCREW RETAINING ROD |
| 00885556343692 | INTERTAN 10S 10MM X 20CM 130D |
| 00885556343647 | INTERTAN 10S 10MM X 20CM 125D |
| 00885556280461 | RAPID TAN 3.2MM X 450MM GUIDE PIN |
| 00885556266649 | CURVED CANNLUATED AWL |
| 00885556266540 | EXTENDED SET SCREW DRIVER |
| 00885556266496 | EXTENDED GUIDE BOLT |
| 00885556266441 | INTERTAN DRILL GUIDE EXTENDED |
| 00885556131886 | 135 RADIOLUCENT DRILL GUIDE DROP |
| 00885556131848 | INTERTAN 1.5 13MM X 30CM 125D LEFT |
| 00885556131831 | INTERTAN 1.5 13MM X 30CM 125D RIGHT |
| 00885556131763 | INTERTAN 1.5 13MM X 44CM 125D LEFT |
| 00885556131756 | INTERTAN 1.5 13MM X 44CM 125D RIGHT |
| 00885556131749 | INTERTAN 1.5 13MM X 46CM 125D LEFT |
| 00885556131732 | INTERTAN 1.5 13MM X 46CM 125D RIGHT |
| 00885556131725 | INTERTAN 1.5 13MM X 30CM 130D LEFT |
| 00885556131718 | INTERTAN 1.5 13MM X 30CM 130D RIGHT |
| 00885556131626 | INTERTAN 1.5 13MM X 44CM 130D LEFT |
| 00885556131619 | INTERTAN 1.5 13MM X 44CM 130D RIGHT |
| 00885556131602 | INTERTAN 1.5 13MM X 46CM 130D LEFT |
| 00885556131596 | INTERTAN 1.5 13MM X 46CM 130D RIGHT |
| 00885556105245 | INTERTAN 11.5MM X 24CM 130D |
| 00885556105191 | INTERTAN 11.5MM X 24CM 125D |
| 00885556105146 | INTERTAN 10MM X 24CM 130D |
| 00885556105092 | INTERTAN 10MM X 24CM 125D |
| 00885556056196 | CANNULATED AWL W/TROCAR |
| 00885556040034 | INTERTAN 1.5 13MM X 28CM 130D LEFT |
| 00885556039809 | INTERTAN 13MM X 44CM 125D RIGHT |
| 00885556039731 | INTERTAN 1.5 13MM X 28CM 125D LEFT |
| 00885556039687 | INTERTAN 13MM X 44CM 125D LEFT |
| 00885556039656 | INTERTAN 1.5 13MM X 26CM 130D RIGHT |
| 00885556039625 | TRIGEN BASE KIT |
| 00885556039564 | INTERTAN 13MM X 30CM 130D RIGHT |
| 00885556039519 | INTERTAN 13MM X 46CM 130D RIGHT |
| 00885556039403 | INTERTAN 1.5 11.5MM X 28CM 130D RIGHT |
| 00885556039380 | INTERTAN 13MM X 26CM 130D RIGHT |
| 00885556039298 | INTERTAN 1.5 13MM X 26CM 125D RIGHT |
Trademark Results [Intertan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTERTAN 78423979 not registered Dead/Abandoned |
Circuit City Stores West Coast, Inc. 2004-05-24 |
 INTERTAN 78348646 2974364 Live/Registered |
Smith & Nephew, Inc. 2004-01-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.