A.L.P.S.® 816235803
GUDID 00887868353093
Biomet Orthopedics, LLC
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00887868353093 |
| NIH Device Record Key | 07235d2d-fff8-45ae-916b-68fac555a22c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | A.L.P.S.® |
| Version Model Number | 8162-35-803 |
| Catalog Number | 816235803 |
| 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 | false |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868353093 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090877
FDA Product Code
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
[00887868353093]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-30 |
| Device Publish Date | 2019-09-20 |
On-Brand Devices [A.L.P.S.®]
Trademark Results [A.L.P.S.]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A.L.P.S. 86414170 not registered Dead/Abandoned |
Biomet C.V. 2014-10-03 |
 A.L.P.S. 86122580 4795950 Live/Registered |
Biomet C.V. 2013-11-19 |
 A.L.P.S. 85887976 not registered Dead/Abandoned |
Biomet C.V. 2013-03-27 |
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