Primary Device ID | 00841132133392 |
NIH Device Record Key | 95c994d4-70fc-4c68-b238-d2bddd01c97a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PediFlex |
Version Model Number | 01-1000-504 |
Catalog Number | 01-1000-504 |
Company DUNS | 796416191 |
Company Name | ORTHOPEDIATRICS CORP. |
Device Count | 1 |
DM Exempt | false |
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 |
Rbremer@orthopediatrics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841132133392 [Primary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-02-15 |
00841132137222 | PEDIFLEX GEN I ROUND TIP STAINLESS STEEL (IMPLANTS, INSTRUMENTS, & CASE) |
00841132137215 | PEDIFLEX GEN I ROUND TIP TITANIUM (IMPLANTS, INSTRUMENTS, & CASE) |
00841132136102 | ROD CUTTER INNER ASSEMBLY |
00841132136096 | ROD CUTTER OUTER ASSEMBLY |
00841132135181 | ROD CUTTER CAP |
00841132133453 | PEDIFLEX RT STAINLESS STEEL IMPLANTS & ACCESSORY SET (IMPLANTS, INSTRUMENTS & CASE) |
00841132133446 | PEDIFLEX STAINLESS STEEL IMPLANTS & ACCESSORY SET (IMPLANTS, INSTRUMENT & CASE) |
00841132133439 | PEDIFLEX IMPLANT #2 TRAY |
00841132133422 | PEDIFLEX INSTRUEMNT # 2 BASE |
00841132133415 | PEDIFLEX TITANIUM SET II (IMPLANT, INSTRUMENT, & CASE) |
00841132133408 | PEDIFLEX RT ACCESSORY LID |
00841132133392 | PEDIFLEX RT LID |
00841132133385 | PEDIFLEX TITANIUM SET II (IMPLANT, INSTRUMENT, & CASE) |
00841132133378 | PEDIFLEX LID |
00841132133361 | PEDIFLEX IMPLANT #1 TRAY |
00841132133354 | PEDIFLEX INSTRUMENT #1 TRAY |
00841132133347 | PEDIFLEX INSTRUMENT #1 BASE |
00841132133330 | INSERT ASSEMBLY |
00841132133323 | PEDIFLEX STERILIZATION CASE - IMPLANTS AND INSTRUMENTS |
00841132133316 | PEDIFLEX STERILIZATION CASE - IMPLANTS AND INSTRUMENTS |
00841132133309 | PEDIFLEX STERILIZATION CASE - INSTRUMENTS |
00841132133293 | PEDIFLEX STERILIZATION CASE - IMPLANTS AND INSTRUMENTS |
00841132133286 | COLLAR, F-TOOL |
00841132133279 | POST - SLIDING, F-TOOL |
00841132133262 | POST, F-TOOL |
00841132133255 | BAR, F-TOOL |
00841132133248 | 3.0, 3.5 & 4.0 MM LARGE PUNCH |
00841132133231 | 2 & 2.5 MM SMALL PUNCH |
00841132133224 | EXTRACTOR |
00841132133217 | INTRODUCER TOMMY BAR |
00841132133200 | NAIL INTRODUCER |
00841132119716 | ø4.0mm x 450mm Round Tip Flexible IM Nail |
00841132119709 | ø3.5mm x 400mm Round Tip Flexible IM Nail |
00841132119693 | ø3.0mm x 400mm Round Tip Flexible IM Nail |
00841132119686 | ø2.5mm x 300mm Round Tip Flexible IM Nail |
00841132119679 | ø2.0mm x 300mm Round Tip Flexible IM Nail |
00841132119662 | ø1.5mm x 300mm Round Tip Flexible IM Nail |
00841132119587 | 4.0mm Flex Nail Cap SS |
00841132119570 | 3.5mm Flex Nail Cap SS |
00841132119563 | 3.0mm Flex Nail Cap SS |
00841132119556 | 2.5mm Flex Nail Cap SS |
00841132119549 | 2.0mm Flex Nail Cap SS |
00841132119532 | 1.5mm Flex Nail Cap SS |
00841132144169 | F-TOOL COIN |
00840194405973 | PediFlex Adv clamp lid |
00840194405966 | PediFlex Adv clamp case |
00840194405959 | PediFlex clamp guide, 4.Xmm |
00840194405942 | PediFlex clamp guide, 3.Xmm |
00840194405935 | 2.5mm hex driver |
00840194405928 | PediFlex clamp Ti, 4.5mm left |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PEDIFLEX 77421180 not registered Dead/Abandoned |
Q Marketing Group, Ltd. 2008-03-13 |