Guardia K-MVOL-701710-PS-ET

GUDID 00827002538696

Guardia ProET Protective Embryo Transfer Catheter With Echotip,

COOK INCORPORATED

Assisted reproduction transfer catheter/set

• Primary Device ID: 00827002538696
• NIH Device Record Key: a0b7d46b-df50-404c-ab63-c07ca17bf0c7
• Commercial Distribution Discontinuation: 2019-08-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Guardia
• Version Model Number: G53869
• Catalog Number: K-MVOL-701710-PS-ET
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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: true
• 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(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002538696 [Primary]

FDA Product Code

• MQF: CATHETER, ASSISTED REPRODUCTION

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: 2019-09-02
• Device Publish Date: 2016-09-24

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• 00827002538696: Guardia ProET Protective Embryo Transfer Catheter With Echotip,
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• 00827002347823: Guardia Access Embryo Transfer Catheter
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• 00827002242166: Guardia Access Nano Embryo Transfer Catheter
• 00827002242159: Guardia Access Nano Embryo Transfer Catheter