OrthoPediatrics PediFlex Flexible Nail System 00-1000-320

GUDID 00841132119495

ø2.0mm x 300mm Flexible IM Nail

ORTHOPEDIATRICS CORP.

Femur nail, sterile
Primary Device ID00841132119495
NIH Device Record Key71b9a6c1-c6ee-47f7-8f83-4d59221e79a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoPediatrics PediFlex Flexible Nail System
Version Model Number00-1000-320
Catalog Number00-1000-320
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132119495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-08

On-Brand Devices [OrthoPediatrics PediFlex Flexible Nail System]

00841132119655ø4.5mm x 450mm Round Tip Flexible IM Nail
00841132119648ø4.0mm x 450mm Round Tip Flexible IM Nail
00841132119631ø3.5mm x 400mm Round Tip Flexible IM Nail
00841132119624ø3.0mm x 400mm Round Tip Flexible IM Nail
00841132119617ø2.5mm x 300mm Round Tip Flexible IM Nail
00841132119600ø2.0mm x 300mm Round Tip Flexible IM Nail
00841132119594ø1.5mm x 300mm Round Tip Flexible IM Nail
00841132119525ø3.5mm x 400mm Flexible IM Nail
00841132119518ø3.0mm x 400mm Flexible IM Nail
00841132119501ø2.5mm x 300mm Flexible IM Nail
00841132119495ø2.0mm x 300mm Flexible IM Nail
00841132119488ø1.5mm x 300mm Flexible IM Nail
00841132119471ø4.5mm Flexible IM Nail Cap (2 Each)
00841132119464ø4.0mm Flexible IM Nail Cap (2 Each)
00841132119457ø3.5mm Flexible IM Nail Cap (2 Each)
00841132119440ø3.0mm Flexible IM Nail Cap (2 Each)
00841132119433ø2.5mm Flexible IM Nail Cap (2 Each)
00841132119426ø2.0mm Flexible IM Nail Cap (2 Each)
00841132119419ø1.5mm Flexible IM Nail Cap (2 Each)
00841132119402ø4.5mm x 450mm Flexible IM Nail
00841132119396ø4.0mm x 450mm Flexible IM Nail
00841132119389ø3.5mm x 400mm Flexible IM Nail
00841132119372ø3.0mm x 400mm Flexible IM Nail
00841132119365ø2.5mm x 300mm Flexible IM Nail
00841132119358ø1.5mm x 300mm Flexible IM Nail
00841132100059Ø2.0 MM X 300 MM FLEXIBLE IM NAIL

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.