TIMX 325005SS
GUDID 10705034241470
TIMX LOW BACK SYSTEM SET SCREW-METRIC THREAD M7 9.30mm
DEPUY SPINE, LLC
Spinal bone set screw| Primary Device ID | 10705034241470 |
| NIH Device Record Key | e117d4c2-b173-4ce8-a5a3-a0c3255da66e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIMX |
| Version Model Number | 325005SS |
| Catalog Number | 325005SS |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, LLC |
| 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 | true |
| 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)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034241470 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K953978
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
[10705034241470]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [TIMX]
| 10705034008349 | TIMX LOW BACK SYSTEM TORQUE WRENCH-SHAFT |
| 10705034241463 | TIMX LOW BACK SYSTEM HEXLOBE SET SCREW M6 9.30mm |
| 10705034000596 | TIMX LOW BACK SYSTEM HEXLOBE DRIVER |
| 10705034241470 | TIMX LOW BACK SYSTEM SET SCREW-METRIC THREAD M7 9.30mm |
Trademark Results [TIMX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIMX 76176931 2623530 Live/Registered |
DePuy Synthes, Inc. 2000-12-07 |
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