Wallace SurePro Ultra Embryo Replacement Catheter

GUDID 30888937021289

Wallace SurePro Ultra Embryo Replacement Catheter, Soft 23 cm (Box of 10)

Coopersurgical, Inc.

Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set

• Primary Device ID: 30888937021289
• NIH Device Record Key: bfaed6d7-9694-456c-984b-eef5da4c9630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wallace SurePro Ultra Embryo Replacement Catheter
• Version Model Number: PE623
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter
• Catheter Length: 23 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937021288 [Primary]
GS1	20888937021282 [Package]; Contains: 00888937021288; Package: Box [10 Units]; In Commercial Distribution
GS1	30888937021289 [Package]; Contains: 20888937021282; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990349

FDA Product Code

• MQF: Catheter, Assisted Reproduction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-12-04

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