Primary Device ID | 00841132150627 |
NIH Device Record Key | 94900513-3db2-42a8-8134-307ce9f1339a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BandLoc DUO |
Version Model Number | 10-1102-1555 |
Catalog Number | 10-1102-1555 |
Company DUNS | 796416191 |
Company Name | ORTHOPEDIATRICS CORP. |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841132150627 [Primary] |
OWI | Bone Fixation Cerclage, Sublaminar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-18 |
Device Publish Date | 2020-02-10 |
00840194465137 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Solid T10 |
00840194465144 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Solid T15 |
00840194465151 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Cannulated T15 |
00840194465168 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Solid T20 |
00840194465182 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Solid 2.5mm Hex |
00840194465199 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Cannulated 2.5mm Hex |
00840194465205 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Solid 3.0mm Hex |
00840194465212 - OrthoPediatrics Hardware Removal | 2024-04-23 Driver, Cannulated 3.0mm Hex |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BANDLOC DUO 88056181 5886601 Live/Registered |
OrthoPediatrics Corp. 2018-07-27 |