BoneCam
GUDID 10818614020997
VALERIS MEDICAL LLC
Tendon/ligament bone anchor, non-bioabsorbable| Primary Device ID | 10818614020997 |
| NIH Device Record Key | 368fed16-c5f2-4d3b-a05e-c0dc7f09d381 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BoneCam |
| Version Model Number | 08-11120 |
| Company DUNS | 079444554 |
| Company Name | VALERIS MEDICAL 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818614020990 [Primary] |
| GS1 | 10818614020997 [Package] Contains: 00818614020990 Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152255
FDA Product Code
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2017-08-17 |
On-Brand Devices [BoneCam]
Trademark Results [BoneCam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BONECAM 86944109 5134684 Live/Registered |
Valeris Medical 2016-03-17 |
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