PREASSEMBLED SURGICAL WASH SET

GUDID 38033178105225

SORIN GROUP ITALIA SRL

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• Primary Device ID: 38033178105225
• NIH Device Record Key: 8995ceb4-7228-4c71-94db-c9380142f581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREASSEMBLED SURGICAL WASH SET
• Version Model Number: WS-125E
• Company DUNS: 442126587
• Company Name: SORIN GROUP ITALIA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	08033178105224 [Primary]
GS1	38033178105225 [Package]; Contains: 08033178105224; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103202

FDA Product Code

• CAC: APPARATUS, AUTOTRANSFUSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-01-08
• Device Publish Date: 2015-07-15

On-Brand Devices [PREASSEMBLED SURGICAL WASH SET]

• 38033178105249: WS-225E
• 38033178105232: WS-175E
• 38033178105225: WS-125E
• 38033178105218: WS-55E
• 38033178105201: COD.740E - 225 ML BOWL
• 38033178105188: COD.740E - 175 ML BOWL
• 38033178105164: COD.740E - 125 ML BOWL
• 38033178105140: COD.740E - 55 ML BOWL
• 38033178105089: WS-55C
• 38033178105072: WS-225C
• 38033178105058: WS-125C
• 38033178105041: COD.740C-55 ML BOWL
• 38033178105034: COD.740C-225 ML BOWL
• 38033178105027: COD.740C-175 ML BOWL
• 38033178105010: COD.740C-125 ML BOWL