16G Wallace Single Lumen Oocyte Recovery Set

GUDID 30888937021043

16G Wallace Single Lumen Oocyte Recovery Set, 950 mm tubing (Box of 10)

Coopersurgical, Inc.

IVF oocyte aspiration needle, single-use

• Primary Device ID: 30888937021043
• NIH Device Record Key: e6290e26-0d5f-42fe-9dde-820772e3902e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16G Wallace Single Lumen Oocyte Recovery Set
• Version Model Number: ONS1633
• 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

• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge
• Length: 950 Millimeter
• Needle Gauge: 16 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937021042 [Primary]
GS1	20888937021046 [Package]; Contains: 00888937021042; Package: Box [10 Units]; In Commercial Distribution
GS1	30888937021043 [Package]; Contains: 20888937021046; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000628

FDA Product Code

• MQE: Needle, 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

On-Brand Devices [16G Wallace Single Lumen Oocyte Recovery Set]

• 30888937021067: 16G Wallace Single Lumen Oocyte Recovery Set, 750 mm tubing (Box of 10)
• 30888937021050: 16G Wallace Single Lumen Oocyte Recovery Set, 500 mm tubing (Box of 10)
• 30888937021043: 16G Wallace Single Lumen Oocyte Recovery Set, 950 mm tubing (Box of 10)
• 30888937020978: 16G Wallace Single Lumen Oocyte Recovery Set, 750 mm tubing, flushing connector (Box of 10)
• 30888937020961: 16G Wallace Single Lumen Oocyte Recovery Set, 500 mm tubing, flushing connector (Box of 10)
• 30888937020954: 16G Wallace Single Lumen Oocyte Recovery Set, 950 mm tubing, flushing connector (Box of 10)