Proximal Humeral Plate 21137-5

GUDID 09120069813609

Proximal Humeral Plate, AP Flange, Large, 5-Hole

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120069813609
• NIH Device Record Key: 0a72e3d6-5e14-42a7-b465-10afcd112e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Humeral Plate
• Version Model Number: 21137-5
• Catalog Number: 21137-5
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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	09120069813609 [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

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

[09120069813609]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-08
• Device Publish Date: 2018-03-02

On-Brand Devices [Proximal Humeral Plate]

• 09120069813630: Proximal Humeral Plate, Flange, Left, 5-Hole
• 09120069813623: Proximal Humeral Plate, Flange, Right, 5-Hole
• 09120069813616: Proximal Humeral Plate, AP Flange, Large, 7-Hole
• 09120069813609: Proximal Humeral Plate, AP Flange, Large, 5-Hole
• 09120069813593: Proximal Humeral Plate, AP Flange, Small, 7-Hole
• 09120069813586: Proximal Humeral Plate, AP Flange, Small, 5-Hole
• 09120069813579: Proximal Humeral Plate, SAP Flange, Large, 5-Hole
• 09120069813562: Proximal Humeral Plate, SAP Flange, Small, 5-Hole
• 09120047297360: Proximal Humeral Plate, 7-Hole
• 09120047297353: Proximal Humeral Plate, 4-Hole
• 09120047297346: Proximal Humeral Plate, 10-Hole