CrossFix® II Meniscal Repair Device CM-8002
GUDID 00887868270055
CAYENNE MEDICAL, INC.
Tendon/ligament bone anchor, non-bioabsorbable| Primary Device ID | 00887868270055 |
| NIH Device Record Key | 64e7a125-08d5-4c31-a302-d5f38592dac9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CrossFix® II Meniscal Repair Device |
| Version Model Number | CM8002 |
| Catalog Number | CM-8002 |
| Company DUNS | 606719685 |
| Company Name | CAYENNE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 00887868270055 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121413
FDA Product Code
| GAT | Suture, nonabsorbable, synthetic, polyethylene |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-09 |
| Device Publish Date | 2023-09-29 |
On-Brand Devices [CrossFix® II Meniscal Repair Device]
| 00887868270055 | CM8002 |
| 00887868270048 | CM8001 |
Trademark Results [CrossFix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CROSSFIX 79223623 5563214 Live/Registered |
Ejot Baubefestigungen GmbH 2017-10-02 |
 CROSSFIX 77610046 3740999 Live/Registered |
Cayenne Medical, Inc. 2008-11-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.