Gen II Cannulated Screws 01-1400-0240

GUDID 00840194478540

3x3 Wire Guide, 1.25/1.6mm

ORTHOPEDIATRICS CORP.

Surgical drill guide, reusable

• Primary Device ID: 00840194478540
• NIH Device Record Key: e60a0f14-d979-481f-b2bf-403a7f3c3f73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gen II Cannulated Screws
• Version Model Number: 01-1400-0240
• Catalog Number: 01-1400-0240
• 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	00840194478540 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

[00840194478540]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-02
• Device Publish Date: 2024-07-25

On-Brand Devices [Gen II Cannulated Screws]

• 00840194478557: 3x3 Wire Guide, 2.0/2.5mm
• 00840194478540: 3x3 Wire Guide, 1.25/1.6mm