PRS Plate 21195-14

GUDID 09120034302763

PRS Plate, 14-Hole, Curved, R108

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034302763
• NIH Device Record Key: 3ad6c96d-e60e-4936-bc17-5d44d4b20b22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRS Plate
• Version Model Number: 21195-14
• Catalog Number: 21195-14
• 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	09120034302763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063166

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

Moist Heat or Steam Sterilization

[09120034302763]

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: 2016-09-05

On-Brand Devices [PRS Plate]

• 09120034302923: PRS Plate, 10-Hole, Straight
• 09120034302916: PRS Plate, 11-Hole, Straight
• 09120034302909: PRS Plate, 12-Hole, Straight
• 09120034302893: PRS Plate, 13-Hole, Straight
• 09120034302886: PRS Plate, 14-Hole, Straight
• 09120034302879: PRS Plate, 10-Hole, Curved, R88
• 09120034302862: PRS Plate, 12-Hole, Curved, R88
• 09120034302855: PRS Plate, 14-Hole, Curved, R88
• 09120034302848: PRS Plate, 16-Hole, Curved, R88
• 09120034302831: PRS Plate, 4-Hole, Curved, R88
• 09120034302824: PRS Plate, 5-Hole, Curved, R88
• 09120034302817: PRS Plate, 6-Hole, Curved, R88
• 09120034302800: PRS Plate, 7-Hole, Curved, R88
• 09120034302794: PRS Plate, 8-Hole, Curved, R88
• 09120034302787: PRS Plate, 10-Hole, Curved, R108
• 09120034302770: PRS Plate, 12-Hole, Curved, R108
• 09120034302763: PRS Plate, 14-Hole, Curved, R108
• 09120034302756: PRS Plate, 16-Hole, Curved, R108
• 09120034302749: PRS Plate, 4-Hole, Curved, R108
• 09120034302732: PRS Plate, 5-Hole, Curved, R108
• 09120034302725: PRS Plate, 6-Hole, Curved, R108
• 09120034302718: PRS Plate, 7-Hole, Curved, R108
• 09120034302701: PRS Plate, 8-Hole, Curved, R108