Radius Plate PROlock II 21036-3

GUDID 09120047299265

Radius Plate PROlock II, Small, 3-Hole, Left

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120047299265
• NIH Device Record Key: 59c56d2a-13bb-41ab-8635-ce19f4008e98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radius Plate PROlock II
• Version Model Number: 21036-3
• Catalog Number: 21036-3
• 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	09120047299265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033756

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

Moist Heat or Steam Sterilization

[09120047299265]

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: 2016-09-01

On-Brand Devices [Radius Plate PROlock II]

• 09120047299265: Radius Plate PROlock II, Small, 3-Hole, Left
• 09120047299258: Radius Plate PROlock II, Small, 3-Hole, Right
• 09120047296974: Radius Plate PROlock II, 9-Hole, Left
• 09120047296967: Radius Plate PROlock II, 7-Hole, Left
• 09120047296950: Radius Plate PROlock II, 9-Hole, Right
• 09120047296943: Radius Plate PROlock II, 7-Hole, Right
• 09120047296936: Radius Plate PROlock II, Wide, 5-Hole, Left
• 09120047296929: Radius Plate PROlock II, Wide, 3-Hole, Left
• 09120047296912: Radius Plate PROlock II, Wide, 5-Hole, Right
• 09120047296905: Radius Plate PROlock II, Wide, 3-Hole, Right
• 09120047296882: Radius Plate PROlock II, 5-Hole, Left
• 09120047296875: Radius Plate PROlock II, 5-Hole, Right
• 09120047296479: Radius Plate PROlock II, 3-Hole, Left
• 09120047296462: Radius Plate PROlock II, 3-Hole, Right
• 09120034307997: Radius Plate PROlock II, 11-Hole, Left
• 09120034307973: Radius Plate PROlock II, 11-Hole, Right