Straight Plate, 4.5mm 21103-10

GUDID 09120034304750

Straight Plate, 4.5mm, 10-Hole

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034304750
• NIH Device Record Key: e49f917b-536c-44b7-a0d5-da20239a1736
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Plate, 4.5mm
• Version Model Number: 21103-10
• Catalog Number: 21103-10
• 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	09120034304750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060156

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

Moist Heat or Steam Sterilization

[09120034304750]

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: 2016-09-08

On-Brand Devices [Straight Plate, 4.5mm]

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• 09120034304828: Straight Plate, 4.5mm, 8-Hole
• 09120034304811: Straight Plate, 4.5mm, 7-Hole
• 09120034304804: Straight Plate, 4.5mm, 6-Hole
• 09120034304798: Straight Plate, 4.5mm, 5-Hole
• 09120034304781: Straight Plate, 4.5mm, 13-Hole
• 09120034304774: Straight Plate, 4.5mm, 12-Hole
• 09120034304767: Straight Plate, 4.5mm, 11-Hole
• 09120034304750: Straight Plate, 4.5mm, 10-Hole