Stratis 8304SS
GUDID 10884521513853
Retractable Switching Stick
Covidien LP
Meniscus screw| Primary Device ID | 10884521513853 |
| NIH Device Record Key | 9a0342d8-cab6-40c0-8903-d07641304271 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stratis |
| Version Model Number | 8304SS |
| Catalog Number | 8304SS |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521513853 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041749
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
[10884521513853]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Stratis]
| 10884521513853 | Retractable Switching Stick |
| 10884521513839 | Drill Tipped Guide Wire |
| 10884521513822 | Cannulated Acorn Drill Bit |
| 10884521513815 | Cannulated Acorn Drill Bit |
| 10884521513808 | Cannulated Acorn Drill Bit |
| 10884521513792 | Cannulated Drill Bit |
| 10884521513785 | Cannulated Drill Bit |
| 10884521513778 | Cannulated Drill Bit |
| 10884521513693 | ACL Reconstruction Graft Conditioning/Sizng Block |
| 10884521513686 | Transverse Drill |
| 10884521513679 | ACL System Sterilization Tray |
| 10884521513648 | Transverse Drill Sleeve |
| 10884521513624 | Drill Guide Handle Locking Nut |
| 10884521513617 | Transverse Drill Guide |
| 10884521513570 | Fixation Pin Inserter |
| 10884521513549 | ACL Femoral Reconstruction System Kit |
| 10884521513754 | ACL Soft Tissue Femoral Fixation Implant;Graft Block and 40 mm Fixation Pin |
| 10884521513730 | ACL Soft Tissue Femoral Fixation Implant;Graft Block and 40 mm Fixation Pin |
| 10884521513716 | ACL Soft Tissue Femoral Fixation Implant;Graft Block and 40 mm Fixation Pin |
Trademark Results [Stratis]
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