Orthopediatric Instrumentation 01-9100-4532

GUDID 00840194405348

3.2mm THREADED DRILL GUIDE

ORTHOPEDIATRICS CORP.

Surgical drill guide, reusable

• Primary Device ID: 00840194405348
• NIH Device Record Key: 134ac06e-0713-4494-b646-ea7859438d7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopediatric Instrumentation
• Version Model Number: 01-9100-4532
• Catalog Number: 01-9100-4532
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194405348 [Primary]

FDA Product Code

• FZX: Guide, surgical, instrument

Sterilization

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

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

[00840194405348]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-07-04
• Device Publish Date: 2021-09-01

On-Brand Devices [Orthopediatric Instrumentation]

• 00840194405355: 1.6mm THREADED WIRE GUIDE
• 00840194405331: 2.0mm THREADED WIRE GUIDE
• 00840194405386: 5.0mm HEX TOWER GUIDE DRIVER
• 00840194405362: 2.5mm THREADED DRILL GUIDE
• 00840194405348: 3.2mm THREADED DRILL GUIDE