SIJ Plate 21177-4

GUDID 09120034309366

SIJ Plate, Closed, PRS RX System

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034309366
• NIH Device Record Key: 5d027381-84ab-4f87-adc4-620057cbd74a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIJ Plate
• Version Model Number: 21177-4
• Catalog Number: 21177-4
• 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	09120034309366 [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

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

Moist Heat or Steam Sterilization

[09120034309366]

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 [SIJ Plate]

• 09120034309366: SIJ Plate, Closed, PRS RX System
• 09120034309342: SIJ Plate, 5-Hole, PRS RX System
• 09120034302954: SIJ Plate, 5-Hole, Right
• 09120034302947: SIJ Plate, 5-Hole, Left
• 09120034302930: SIJ Plate, 4-Hole, Closed