PNP TIBIA 01-1540-0635

GUDID 00840194467100

NITINOL FLEX SHAFT, 635mm

ORTHOPEDIATRICS CORP.

Medullary canal orthopaedic reamer, flexible

• Primary Device ID: 00840194467100
• NIH Device Record Key: e79bf63c-ae5f-4bf9-979e-4bb8ef93c418
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNP TIBIA
• Version Model Number: 01-1540-0635
• Catalog Number: 01-1540-0635
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194467100 [Primary]

FDA Product Code

• KIJ: Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Sterilization

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

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

[00840194467100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-19
• Device Publish Date: 2024-09-11

On-Brand Devices [PNP TIBIA]

• 00840194466875: FLEXIBLE IM REAMER SHAFT 25IN
• 00840194466585: Large Head Pusher
• 00840194467162: 7.0mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467155: 6.5mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467148: 6.0mm MONOBLOC NITINOL REAMER, 635mm
• 00840194467131: 7.0mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467124: 6.5mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467117: 6.0mm MONOBLOC NITINOL REAMER, 435mm
• 00840194467100: NITINOL FLEX SHAFT, 635mm
• 00840194467094: NITINOL FLEX SHAFT, 435mm