PediFlex 00-1001-0622

GUDID 00840194405836

PediFlex clamp screw Ti, 25mm

ORTHOPEDIATRICS CORP.

Femur nail, sterile
Primary Device ID00840194405836
NIH Device Record Keyf6a0ede3-e728-4f17-b46e-7fb37fcca771
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediFlex
Version Model Number00-1001-0622
Catalog Number00-1001-0622
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com
Phone+1(574)268-6379
Emailyli@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194405836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

[00840194405836]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-04
Device Publish Date2021-02-24

On-Brand Devices [PediFlex]

00841132137222PEDIFLEX GEN I ROUND TIP STAINLESS STEEL (IMPLANTS, INSTRUMENTS, & CASE)
00841132137215PEDIFLEX GEN I ROUND TIP TITANIUM (IMPLANTS, INSTRUMENTS, & CASE)
00841132136102ROD CUTTER INNER ASSEMBLY
00841132136096ROD CUTTER OUTER ASSEMBLY
00841132135181ROD CUTTER CAP
00841132133453PEDIFLEX RT STAINLESS STEEL IMPLANTS & ACCESSORY SET (IMPLANTS, INSTRUMENTS & CASE)
00841132133446PEDIFLEX STAINLESS STEEL IMPLANTS & ACCESSORY SET (IMPLANTS, INSTRUMENT & CASE)
00841132133439PEDIFLEX IMPLANT #2 TRAY
00841132133422PEDIFLEX INSTRUEMNT # 2 BASE
00841132133415PEDIFLEX TITANIUM SET II (IMPLANT, INSTRUMENT, & CASE)
00841132133408PEDIFLEX RT ACCESSORY LID
00841132133392PEDIFLEX RT LID
00841132133385PEDIFLEX TITANIUM SET II (IMPLANT, INSTRUMENT, & CASE)
00841132133378PEDIFLEX LID
00841132133361PEDIFLEX IMPLANT #1 TRAY
00841132133354PEDIFLEX INSTRUMENT #1 TRAY
00841132133347PEDIFLEX INSTRUMENT #1 BASE
00841132133330INSERT ASSEMBLY
00841132133323PEDIFLEX STERILIZATION CASE - IMPLANTS AND INSTRUMENTS
00841132133316PEDIFLEX STERILIZATION CASE - IMPLANTS AND INSTRUMENTS
00841132133309PEDIFLEX STERILIZATION CASE - INSTRUMENTS
00841132133293PEDIFLEX STERILIZATION CASE - IMPLANTS AND INSTRUMENTS
00841132133286COLLAR, F-TOOL
00841132133279POST - SLIDING, F-TOOL
00841132133262POST, F-TOOL
00841132133255BAR, F-TOOL
008411321332483.0, 3.5 & 4.0 MM LARGE PUNCH
008411321332312 & 2.5 MM SMALL PUNCH
00841132133224EXTRACTOR
00841132133217INTRODUCER TOMMY BAR
00841132133200NAIL INTRODUCER
00841132119716ø4.0mm x 450mm Round Tip Flexible IM Nail
00841132119709ø3.5mm x 400mm Round Tip Flexible IM Nail
00841132119693ø3.0mm x 400mm Round Tip Flexible IM Nail
00841132119686ø2.5mm x 300mm Round Tip Flexible IM Nail
00841132119679ø2.0mm x 300mm Round Tip Flexible IM Nail
00841132119662ø1.5mm x 300mm Round Tip Flexible IM Nail
008411321195874.0mm Flex Nail Cap SS
008411321195703.5mm Flex Nail Cap SS
008411321195633.0mm Flex Nail Cap SS
008411321195562.5mm Flex Nail Cap SS
008411321195492.0mm Flex Nail Cap SS
008411321195321.5mm Flex Nail Cap SS
00841132144169F-TOOL COIN
00840194405973PediFlex Adv clamp lid
00840194405966PediFlex Adv clamp case
00840194405959PediFlex clamp guide, 4.Xmm
00840194405942PediFlex clamp guide, 3.Xmm
008401944059352.5mm hex driver
00840194405928PediFlex clamp Ti, 4.5mm left

Trademark Results [PediFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEDIFLEX
PEDIFLEX
77421180 not registered Dead/Abandoned
Q Marketing Group, Ltd.
2008-03-13
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