Synovasure® Alpha Defensin 00-8888-125-10
GUDID 00887868540677
CD DIAGNOSTICS, INC.
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| NIH Device Record Key | a907c2d7-4f82-49da-be29-fe05eb44cf07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synovasure® Alpha Defensin |
| Version Model Number | 00-8888-125-10 |
| Catalog Number | 00-8888-125-10 |
| Company DUNS | 027871090 |
| Company Name | CD DIAGNOSTICS, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868540677 [Primary] |
| GS1 | 70887868540676 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN180032
FDA Product Code
| QGN | Lateral flow immunochromatography assay for host infection biomarkers |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
[00887868540677]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-14 |
| Device Publish Date | 2022-02-04 |
On-Brand Devices [Synovasure® Alpha Defensin]
| 00887868540691 | 00-8888-125-02 |
| 00887868540684 | 00-8888-125-30 |
| 00887868540677 | 00-8888-125-10 |
| 00887868540653 | 00-8888-125-01 |
| 70887868540669 | 00-8888-125-05 |
Trademark Results [Synovasure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNOVASURE 90905858 not registered Live/Pending |
Zimmer, Inc. 2021-08-27 |
 SYNOVASURE 85765612 4506612 Live/Registered |
Zimmer, Inc. 2012-10-29 |
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