WIN SYSTEM 240704
GUDID 00880304285736
Biomet Orthopedics, LLC
Orthopaedic bone screw, non-bioabsorbable, sterile Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length Arthrodesis nail, fixed-length| Primary Device ID | 00880304285736 |
| NIH Device Record Key | 156a7abe-77da-4e1c-9ba7-698724cdd2a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WIN SYSTEM |
| Version Model Number | 240704 |
| Catalog Number | 240704 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304285736 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K000764
FDA Product Code
| JDS | NAIL, FIXATION, BONE |
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 [WIN SYSTEM]
| 00880304492714 | 240705 |
| 00880304487277 | 240703 |
| 00880304487260 | 240701 |
| 00880304285736 | 240704 |
| 00880304285729 | 240702 |
| 00880304285712 | 240700 |
Trademark Results [WIN SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WIN SYSTEM 74132051 1678915 Dead/Cancelled |
Associated Rehabilitation Services, Inc. 1991-01-22 |
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