Primary Device ID | 00840124507159 |
NIH Device Record Key | 9b3d7746-6e73-4fcc-8fce-7e2bba3b5876 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PolyLock Small Bone |
Version Model Number | CD-SB-0027 |
Catalog Number | CD-SB-0027 |
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 | 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 | 00840124507159 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
[00840124507159]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-31 |
Device Publish Date | 2022-10-21 |
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 |