PediFlex 00-1000-615

GUDID 00841132119662

ø1.5mm x 300mm Round Tip Flexible IM Nail

ORTHOPEDIATRICS CORP.

Femur nail, sterile

• Primary Device ID: 00841132119662
• NIH Device Record Key: 548c0ed9-c4d1-46e7-a740-a11b86a83677
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediFlex
• Version Model Number: 00-1000-615
• Catalog Number: 00-1000-615
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com
• Phone: +1(574)268-6379
• Email: Rbremer@orthopediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132119662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082375

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-08

On-Brand Devices [PediFlex]

• 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