0212-013-000

GUDID 34546540184819

Full Perforation Flat Silicone Wound Drain

STRYKER CORPORATION

Whole-blood-recovery autotransfusion system, powered

• Primary Device ID: 34546540184819
• NIH Device Record Key: 0f46f63b-f425-4987-bc70-b2627d2ae8f4
• Commercial Distribution Discontinuation: 2019-04-01
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 0212013000
• Catalog Number: 0212-013-000
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• 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

Customer Support Contacts

• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540184818 [Primary]
GS1	34546540184819 [Package]; Contains: 04546540184818; Package: pack [10 Units]; Discontinued: 2019-04-01; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970714

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: 2020-02-19
• Device Publish Date: 2015-09-24

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