Proximal Humeral Plate, Standard, 10-Hole

GUDID 09120116972174

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120116972174
• NIH Device Record Key: 4a12fb3d-a88c-4cc1-bbea-9272bbb86f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Humeral Plate, Standard, 10-Hole
• Version Model Number: 211341-10
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	09120116972174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051412

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

[09120116972174]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-08-08
• Device Publish Date: 2022-12-27

Devices Manufactured by I.T.S. GmbH

• 09120034304392 - Washer, Flat: 2024-11-11 Washer, Flat, AD=14,0mm, ID=7,0mm
• 09120047290026 - Fixation Screw: 2024-11-11 Fixation Screw, PRS upgrade system
• 09120047290071 - Bolt: 2024-11-11 Bolt, PRS upgrade system
• 09120047297742 - Spike Short: 2024-11-11 Spike Short, PRS upgrade system
• 09120047306345 - Fixation Screw: 2024-11-11 Fixation Screw, PRS RXsystem
• 09120047306352 - Bolt: 2024-11-11 Bolt, PRS RX System
• 09120047306369 - Spike Short: 2024-11-11 Spike Short, PRS RX system
• 09120034300196 - Spike: 2024-10-01 Spike, WS 7, PRS Set