Affixus® Hip Fracture Nail 814509440
GUDID 00887868566370
Biomet Orthopedics, LLC
Femur nail| Primary Device ID | 00887868566370 |
| NIH Device Record Key | a7c1b8ce-3f21-4f10-bc55-4e6d8f306a06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affixus® Hip Fracture Nail |
| Version Model Number | 8145-09-440 |
| Catalog Number | 814509440 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868566370 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100238
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 | 2023-06-06 |
| Device Publish Date | 2023-05-29 |
On-Brand Devices [Affixus® Hip Fracture Nail]
Trademark Results [Affixus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFIXUS 77944955 3912289 Live/Registered |
BIOMET C.V. 2010-02-25 |
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