Soft-Pass J-SP-201820-GC

GUDID 00827002191297

Soft-Pass Obturator With Guide Catheter

COOK INCORPORATED

Assisted reproduction transfer catheter/set

• Primary Device ID: 00827002191297
• NIH Device Record Key: 41c0c012-007d-4441-bd6f-3e71c762642b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soft-Pass
• Version Model Number: G19129
• Catalog Number: J-SP-201820-GC
• 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	00827002191297 [Primary]

FDA Product Code

• MFD: CANNULA, INTRAUTERINE INSEMINATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-24

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• 00827002272064: Echotip, Soft-Pass Embryo Transfer Catheter
• 00827002191297: Soft-Pass Obturator With Guide Catheter
• 00827002190849: Echotip, Soft-Pass Catheter Inner Catheter With Cannula
• 00827002189553: Echotip, Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula
• 00827002189546: Echotip, Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula
• 00827002187344: Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula
• 00827002186583: Echotip, Soft-Pass Embryo Transfer Catheter
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• 00827002179318: Soft-Pass Embryo Transfer Catheter Inner Catheter With Cannula
• 00827002179301: Soft-Pass Embryo Transfer Catheter
• 00827002179127: Soft-Pass Insemination Catheter
• 00827002179028: Soft-Pass Embryo Transfer Catheter
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• 00827002176508: Soft-Pass Catheter
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