Olecranon Hook Plate, Locking 21113-9

GUDID 09120047293836

Olecranon Hook Plate, Locking, 9-Hole, right

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120047293836
• NIH Device Record Key: 122befdc-1fa7-4fcb-a976-81cbc99bbe8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olecranon Hook Plate, Locking
• Version Model Number: 21113-9
• Catalog Number: 21113-9
• 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	09120047293836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052368

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

Moist Heat or Steam Sterilization

[09120047293836]

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: 2016-09-07

On-Brand Devices [Olecranon Hook Plate, Locking]

• 09120047297001: Olecranon Hook Plate, Locking, 5-Hole, right/left
• 09120047296998: Olecranon Hook Plate, Locking, 7-Hole, left
• 09120047296981: Olecranon Hook Plate, Locking, 7-Hole, right
• 09120047293843: Olecranon Hook Plate, Locking, 9-Hole, left
• 09120047293836: Olecranon Hook Plate, Locking, 9-Hole, right