VERSANAIL®TROCH ENTRY NAIL - RIGHT 181411420
GUDID 00887868020667
Biomet Orthopedics, LLC
Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail| Primary Device ID | 00887868020667 |
| NIH Device Record Key | f4550a43-521d-4f8c-8eac-03dea08fa6f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERSANAIL®TROCH ENTRY NAIL - RIGHT |
| Version Model Number | 1814-11-420 |
| Catalog Number | 181411420 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, 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 | false |
| 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 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868020667 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033329
FDA Product Code
| JDW | PIN, FIXATION, THREADED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [VERSANAIL®TROCH ENTRY NAIL - RIGHT]
Trademark Results [VERSANAIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSANAIL 78080212 2728157 Live/Registered |
BIOMET C.V. 2001-08-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.