HLS Plate, Y-Shape 21513-5

GUDID 09120047304907

HLS Plate, Y-Shape, 1.0mm, 5-Hole

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120047304907
• NIH Device Record Key: 1c5b6239-77b1-42c6-a101-5894668ef95b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HLS Plate, Y-Shape
• Version Model Number: 21513-5
• Catalog Number: 21513-5
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	09120047304907 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142418

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

[09120047304907]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-09-12

On-Brand Devices [HLS Plate, Y-Shape]

• 09120047304921: HLS Plate, Y-Shape, 1.5mm, 5-Hole
• 09120047304914: HLS Plate, Y-Shape, 1.5mm, 4-Hole
• 09120047304907: HLS Plate, Y-Shape, 1.0mm, 5-Hole
• 09120047304891: HLS Plate, Y-Shape, 1.0mm, 4-Hole
• 09120047304884: HLS Plate, Y-Shape, 1.0mm, 3-Hole
• 09120047303672: HLS Plate, Y-Shape, 1.5mm, 3-Hole