Primary Device ID | 00841132178898 |
NIH Device Record Key | fc939e83-a13c-490d-b0a2-8397045213f0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Response 5.5/6.0 |
Version Model Number | 00-1750-1820 |
Catalog Number | 00-1750-1820 |
Company DUNS | 796416191 |
Company Name | ORTHOPEDIATRICS CORP. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatrics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841132178898 [Primary] |
NKB | Thoracolumbosacral pedicle screw system |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
[00841132178898]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-19 |
Device Publish Date | 2021-02-11 |
00841132191149 | 5.5/6.0 Open/ Open domino connector |
00841132191132 | 5.5/6.0 Open/ Closed wedding band |
00841132191125 | 5.5/6.0 Open/ Open wedding band connector, 20mm |
00841132191118 | 5.5/6.0 Open/ Open wedding band connector, 15mm |
00841132191101 | 5.5/6.0 Open/ Open wedding band connector, 10mm |
00841132191095 | 5.5/6.0 double open lateral connector, 80mm |
00841132191088 | 5.5/6.0 double open lateral connector, 60mm |
00841132191071 | 5.5/6.0 double open lateral connector, 40mm |
00841132191064 | 5.5/6.0 closed lateral connector, 60mm |
00841132191057 | 5.5/6.0 closed lateral connector, 40mm |
00841132191040 | 5.5/6.0 closed lateral connector, 20mm |
00841132191033 | 5.5/6.0 closed stopper |
00841132178911 | 5.5/6.0 Elevated polyaxial lateral connector, 40mm |
00841132178898 | 5.5/6.0 Elevated polyaxial lateral connector, 20mm |
00840194405287 | 5.5/6.0 2 screw open lateral, 20mm |
00840194405270 | 5.5/6.0 closed lateral connector, 80mm |