PediFrag 01-1005-0036

GUDID 00841132122709

T10 HEXALOBE DRIVER, SHORT

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00841132122709
• NIH Device Record Key: c3d5f034-c569-4a4f-b920-264588e67537
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediFrag
• Version Model Number: 01-1005-0036
• Catalog Number: 01-1005-0036
• 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	00841132122709 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

[00841132122709]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-22

On-Brand Devices [PediFrag]

• 00841132138380: 3.5MM CLAVICLE PLATE, 5 HOLE, LEFT
• 00841132138373: 3.5MM CLAVICLE PLATE, 7 HOLE, RIGHT
• 00841132138366: 3.5MM CLAVICLE PLATE, 5 HOLE, RIGHT
• 00841132138359: 3.5MM CLAVICLE PLATE, 10 HOLE, LEFT
• 00841132138342: 3.5MM CLAVICLE PLATE, 8 HOLE, LEFT
• 00841132138335: 3.5MM CLAVICLE PLATE, 6 HOLE, LEFT
• 00841132138328: 3.5MM CLAVICLE PLATE, 4 HOLE, LEFT
• 00841132138311: 3.5MM CLAVICLE PLATE, 10 HOLE, RIGHT
• 00841132138304: 3.5MM CLAVICLE PLATE, 8 HOLE, RIGHT
• 00841132138298: 3.5MM CLAVICLE PLATE, 6 HOLE, RIGHT
• 00841132138281: 3.5MM CLAVICLE PLATE, 4 HOLE, RIGHT
• 00841132138274: 2.7MM CLAVICLE PLATE, 7 HOLE, LEFT
• 00841132138267: 2.7MM CLAVICLE PLATE, 5 HOLE, LEFT
• 00841132138250: 2.7MM CLAVICLE PLATE, 7 HOLE, RIGHT
• 00841132138243: 2.7MM CLAVICLE PLATE, 5 HOLE, RIGHT
• 00841132138236: 2.7MM CLAVICLE PLATE, 10 HOLE, LEFT
• 00841132138229: 2.7MM CLAVICLE PLATE, 8 HOLE, LEFT
• 00841132138212: 2.7MM CLAVICLE PLATE, 6 HOLE, LEFT
• 00841132138205: 2.7MM CLAVICLE PLATE, 4 HOLE, LEFT
• 00841132138199: 2.7MM CLAVICLE PLATE, 10 HOLE, RIGHT
• 00841132138182: 2.7MM CLAVICLE PLATE, 8 HOLE, RIGHT
• 00841132138175: 2.7MM CLAVICLE PLATE, 6 HOLE, RIGHT
• 00841132138168: 2.7MM CLAVICLE PLATE, 4 HOLE, RIGHT
• 00841132137239: PEDIFRAG SMALL AND MINI FRAGMENT SYSTEM (2.7/3.5/4.0) BOM
• 00841132130452: PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL
• 00841132130445: PEDILOC FRAGMENT SYSTEM SCREW CADDY LID
• 00841132130438: PEDILOC FRAGMENT SYSTEM SCREW CADDY
• 00841132130421: PEDILOC FRAGMENT SYSTEM 2.7/3.5- 3.5 TRAY, SMALL
• 00841132130414: PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL
• 00841132130407: PEDIFRAG TRAY, BASE
• 00841132138410: CLAVICLE PLATE LID
• 00841132138403: CLAVICLE PLATE TRAY
• 00841132122716: T10 RETAINING DRIVER, SHORT
• 00841132122709: T10 HEXALOBE DRIVER, SHORT
• 00841132122662: T15 CANNULATED DRIVER, SHORT (DIA 1.25)
• 00841132122655: 2.5 MM X 150 MM GUIDE WIRE, THREADED
• 00841132122648: PLATE FIXATION PIN
• 00841132122631: T15 HEXALOBE DRIVER, RETAINING
• 00841132122624: T10 HEXALOBE DRIVER, RETAINING
• 00841132122617: CANNULATED COUNTERSINK
• 00841132122600: 3.5 MM DRILL BIT
• 00841132122594: 2.7 MM DRILL BIT
• 00841132122587: 2.0 MM CALIBRATED DRILL BIT
• 00841132122570: 2.0 MM DRILL BIT
• 00841132138397: 3.5MM CLAVICLE PLATE, 7 HOLE, LEFT