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 |
00840194493819 - VerteGlide Spinal Growth Guidance System | 2025-07-18 VERTEGLIDE 4.5MM SET SCREW AND ROD CLAMP CADDY |
00840194493840 - VerteGlide Spinal Growth Guidance System | 2025-07-18 VERTEGLIDE 5.5MM SET SCREW AND ROD CLAMP CADDY |
00840194418287 - PedFlex Flexible Nailing System | 2025-07-10 Ø1.5 MM FLEXIBLE IM NAIL CAP (2 EACH) |
00840194419437 - PedFlex Flexible Nailing System | 2025-07-10 PediFlex Clamp SS, 3.0mm Right |
00840194419444 - PedFlex Flexible Nailing System | 2025-07-10 PediFlex Clamp SS, 3.0mm Left |
00840194419451 - PedFlex Flexible Nailing System | 2025-07-10 PediFlex Clamp SS, 3.5mm Right |
00840194419468 - PedFlex Flexible Nailing System | 2025-07-10 PediFlex Clamp SS, 3.5mm Left |
00840194419475 - PedFlex Flexible Nailing System | 2025-07-10 PediFlex Clamp SS, 4.0mm Right |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BANDLOC DUO 88056181 5886601 Live/Registered |
OrthoPediatrics Corp. 2018-07-27 |