Primary Device ID | 00840124506312 |
NIH Device Record Key | c41f7b65-a3c4-4a47-b96d-e8f3bfdf7051 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PolyLock Small Bone |
Version Model Number | SB-LA-3000 |
Catalog Number | SB-LA-3000 |
Company DUNS | 080307067 |
Company Name | FUSION ORTHOPEDICS, LLC |
Device Count | 1 |
DM Exempt | true |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840124506312 [Primary] |
HRS | Plate, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
[00840124506312]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-12-28 |
Device Publish Date | 2021-12-20 |
00840124506329 | Lapidus U Plate Right |
00840124506312 | Lapidus U Plate Left |
00840124506718 | Non-Locking Screw SB 2.7mm x 32mm |
00840124507159 | Olive Wire 2.0mm Threaded |
00840124513730 | TailorsLock Plate (New) |
00840124513723 | TailorsLock Tray |
00840124507487 | MiniLock K-Wire Lag Guide |