Periacetabular Osteotomy System 01-1401-0006

GUDID 00840194478403

PAO Special Pubis Retractor

ORTHOPEDIATRICS CORP.

Hand-held surgical retractor, reusable

• Primary Device ID: 00840194478403
• NIH Device Record Key: a3d34bbb-cb62-477a-8581-a073c9187578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Periacetabular Osteotomy System
• Version Model Number: 01-1401-0006
• Catalog Number: 01-1401-0006
• 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	00840194478403 [Primary]

FDA Product Code

• GAD: RETRACTOR

Sterilization

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

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

[00840194478403]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-07
• Device Publish Date: 2024-05-30

On-Brand Devices [Periacetabular Osteotomy System]

• 00841132128756: PAO TRAY LID
• 00841132128749: PAO TRAY
• 00841132128732: DUAL-SPIKED PUBIS RETRACTOR
• 00841132128725: OFFSET CURVED OSTEOTOME, RIGHT
• 00841132128718: OFFSET CURVED OSTEOTOME, LEFT
• 00840194478502: Single Point Offset Pubis Retractor
• 00840194478403: PAO Special Pubis Retractor