VersaNail® 181709161
GUDID 00887868471421
Biomet Orthopedics, LLC
Humerus nail, sterile| Primary Device ID | 00887868471421 |
| NIH Device Record Key | 01da1238-20f4-459f-8ae8-0b0b12df8131 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaNail® |
| Version Model Number | 1817-09-161 |
| Catalog Number | 181709161 |
| 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 Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868471421 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033329
FDA Product Code
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
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 | 2022-04-04 |
| Device Publish Date | 2022-03-26 |
On-Brand Devices [VersaNail®]
| 00887868472640 | 2810-17-029 |
| 00887868472572 | 2810-17-019 |
| 00887868472558 | 2810-17-015 |
| 00887868472442 | 2810-01-140 |
| 00887868472756 | 2810-18-009 |
| 00887868472732 | 2810-18-007 |
| 00887868471421 | 1817-09-161 |
| 00887868471346 | 1817-08-161 |
| 00887868471513 | 1818-10-015 |
| 00887868471506 | 1818-08-015 |
| 00887868471490 | 1817-09-301 |
| 00887868471483 | 1817-09-281 |
| 00887868471476 | 1817-09-261 |
| 00887868471469 | 1817-09-241 |
| 00887868471452 | 1817-09-221 |
| 00887868471445 | 1817-09-201 |
| 00887868471438 | 1817-09-181 |
| 00887868471414 | 1817-08-301 |
| 00887868471407 | 1817-08-281 |
| 00887868471391 | 1817-08-261 |
| 00887868471384 | 1817-08-241 |
| 00887868471377 | 1817-08-221 |
| 00887868471360 | 1817-08-201 |
| 00887868471353 | 1817-08-181 |
| 00887868471339 | 1817-07-301 |
| 00887868471322 | 1817-07-281 |
| 00887868471315 | 1817-07-261 |
| 00887868471308 | 1817-07-241 |
| 00887868471292 | 1817-07-221 |
| 00887868471285 | 1817-07-201 |
| 00887868471278 | 1817-07-181 |
| 00887868561368 | 2810-13-037 |
Trademark Results [VersaNail]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSANAIL 78080212 2728157 Live/Registered |
BIOMET C.V. 2001-08-20 |
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