SUBFIX SUT0065
GUDID 07613252263494
Arthroeresis Implant
Stryker Trauma SA
Orthopaedic bone staple, non-adjustable, non-sterile| Primary Device ID | 07613252263494 |
| NIH Device Record Key | 58d1fe71-3c61-46f4-be88-e8dd22d21988 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUBFIX |
| Version Model Number | SUT0065 |
| Catalog Number | SUT0065 |
| Company DUNS | 481999654 |
| Company Name | Stryker Trauma SA |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613252263494 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093820
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
[07613252263494]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [SUBFIX]
| 07613252264866 | Trial |
| 07613252264859 | Trial |
| 07613252264842 | Trial |
| 07613252264835 | Trial |
| 07613252264828 | Trial |
| 07613252263531 | Arthroeresis Implant |
| 07613252263524 | Arthroeresis Implant |
| 07613252263517 | Arthroeresis Implant |
| 07613252263500 | Arthroeresis Implant |
| 07613252263494 | Arthroeresis Implant |
| 07613252266990 | Insertion Driver |
| 07613252266754 | Ancillary Set |
| 07613252266433 | Tray with Lid |
| 07613252264729 | Removal Driver |
| 07613252264545 | Guidewire |
Trademark Results [SUBFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUBFIX 98221861 not registered Live/Pending |
Shenzhen Yinshengjin E-commerce Co., Ltd. 2023-10-12 |
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