Primary Device ID | 00840124520769 |
NIH Device Record Key | 36823ee5-a1fb-4270-b1a4-e9143113d2a8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PolyLock Small Bone |
Version Model Number | TN-TR-0061 |
Catalog Number | TN-TR-0061 |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | true |
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 | 00840124520769 [Primary] |
HJO | Biomicroscope, Slit-Lamp, Ac-Powered |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
[00840124520769]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-27 |
Device Publish Date | 2025-05-19 |
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 |
00840124514690 | MiniLock Rotation Arm Right |
00840124519763 | TailorsLock Tray |
00840124520790 | Wedge Caddy |
00840124520783 | Utility Caddy |
00840124520776 | Mini Bunion Tray |
00840124520769 | Lapidus Instrument Caddy |
00840124520752 | Lapidus Implant Caddy |
00840124520745 | Free Basin Caddy |
00840124520738 | Evans Caddy |
00840124520721 | Cotton Caddy |
00840124520714 | Base Tray |
00840124520707 | 5th Metatarsal Caddy |