Primary Device ID | 00841132178485 |
NIH Device Record Key | 1fe9631d-369e-419d-9f92-50a63ff30d4d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Response 5.5/6.0 Spine |
Version Model Number | 01-1300-0031 |
Catalog Number | 01-1300-0031 |
Company DUNS | 796416191 |
Company Name | ORTHOPEDIATRICS CORP. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
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 | 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@orthopediatric.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatric.com | |
Phone | +1(574)268-6379 |
bsmith@orthopediatric.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841132178485 [Primary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00841132178485]
Moist Heat or Steam Sterilization
[00841132178485]
Moist Heat or Steam Sterilization
[00841132178485]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-19 |
Device Publish Date | 2020-05-11 |
00841132137420 | RESPONSE 5.5/6.0 EXTRA LARGE-SIZE SCREW |
00841132137413 | RESPONSE 5.5/6.0 EXTRA LP ROD REDUCTION TOWER |
00841132137406 | RESPONSE 5.5/6.0 EXTRA UNIAXIAL AND POLYAXIAL SCREW |
00841132137390 | RESPONSE 5.5/6.0 EXTRA JIMINY |
00841132137383 | RESPONSE 5.5/6.0 ROD CUTTER |
00841132137376 | RESPONSE 5.5/6.0 FIXED ANGLE SCREW |
00841132137369 | RESPONSE 5.5/6.0 HOOK |
00841132137352 | RESPONSE 5.5/6.0 REDUCTION SCREW |
00841132137345 | RESPONSE 5.5/6.0 POLYAXIAL SCREW |
00841132137338 | RESPONSE 5.5/6.0 UNIAXIAL SCREW |
00841132137321 | RESPONSE 5.5/6.0 COUPLE DEROTATION |
00841132137314 | RESPONSE 5.5/6.0 TORQUE |
00841132137307 | RESPONSE 5.5/6.0 BENDER |
00841132137291 | RESPONSE 5.5/6.0 ROD REDUCTION |
00841132137284 | RESPONSE 5.5/6.0 PEDICLE PREP |
00841132137277 | RESPONSE 5.5/6.0 IMPLANTS & INSTRUMENTS |
00841132145395 | 5.5MM SOLID TAP, DOUBLE LEAD, POWER |
00841132145388 | 4.5MM SOLID TAP, DOUBLE LEAD, POWER |
00841132145371 | 3.5MM SOLID TAP, DOUBLE LEAD, POWER |
00841132178508 | Response 5.5/6.0 Polyaxial Reduction Screw Caddy |
00841132178485 | Response 5.5/6.0 Uniaxial Reduction Screw Caddy |
00841132184677 | NM Case- Tray 3 |
00841132184660 | NM Case- Tray 2 |
00841132184622 | NM Case- Caddy 1 |