PediFlex Advanced 01-1001-9001

GUDID 00841132145685

METAL LID

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132145685
• NIH Device Record Key: 193c2247-103f-4ec9-8bef-c5ba41ccfbd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediFlex Advanced
• Version Model Number: 01-1001-9001
• Catalog Number: 01-1001-9001
• 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: true
• 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: Rzorn@OrthoPediatrics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841132145685 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-30
• Device Publish Date: 2018-03-28

On-Brand Devices [PediFlex Advanced]

• 00841132146019: INSERTER BODY
• 00841132146002: METAL LID, SQUARE
• 00841132145999: INSERTER KNOB, SOLID
• 00841132145982: COLLET, 3.0mm
• 00841132145975: COLLET, 2.5mm
• 00841132145968: COLLET, 2.0mm
• 00841132145951: COLLET, 1.5mm
• 00841132145692: PEDIFLEX CONTAINER 1 ID CARD
• 00841132145685: METAL LID
• 00841132145678: PEDIFLEX TI IMPLANT TRAY
• 00841132145661: PEDIFLEX INSTRUMENT TRAY 1
• 00841132145654: PEDIFLEX ADV - CONTAINER 1
• 00841132145647: PEDIFLEX EXTRACTOR
• 00841132145630: SLOTTED MALLET
• 00841132145623: ROUND TIP 4.5MM X 450MM TI
• 00841132145616: ROUND TIP 4.0MM X 450MM TI
• 00841132145609: ROUND TIP 3.5MM X 400MM TI
• 00841132145593: ROUND TIP 3.0MM X 400MM TI
• 00841132145586: ROUND TIP 2.5MM X 300MM TI
• 00841132145579: ROUND TIP 2.0MM X 300MM TI
• 00841132145562: ROUND TIP 1.5MM X 300MM TI
• 00841132145555: PEDIFLEX CONTAINER 2 ID CARD
• 00841132145548: PEDIFLEX SS IMPLANT TRAY
• 00841132145531: PEDIFLEX INSTRUMENT TRAY 2
• 00841132145524: PEDIFLEX ADV - CONTAINER 2
• 00841132145517: ROUND TIP 4.0MM X 450MM SS
• 00841132145500: ROUND TIP 3.5MM X 400MM SS
• 00841132145494: ROUND TIP 3.0MM X 400MM SS
• 00841132145487: ROUND TIP 2.5MM X 300MM SS
• 00841132145470: ROUND TIP 2.0MM X 300MM SS
• 00841132145463: ROUND TIP 1.5MM X 300MM SS
• 00841132145456: INSERTER TAG
• 00841132145449: PEDIFLEX INSERTER TRAY
• 00841132145432: PEDIFLEX ADV - INSERTER CONTAINER
• 00841132145425: COLLET, 4.5MM
• 00841132145418: COLLET, 4.0MM
• 00841132145401: COLLET, 3.5MM