16G Wallace Single Lumen Oocyte Recovery Set

GUDID 30888937020978

16G Wallace Single Lumen Oocyte Recovery Set, 750 mm tubing, flushing connector (Box of 10)

Coopersurgical, Inc.

IVF oocyte aspiration needle, single-use

• Primary Device ID: 30888937020978
• NIH Device Record Key: 962369c4-3f01-4ce4-8283-e326991c71e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16G Wallace Single Lumen Oocyte Recovery Set
• Version Model Number: ONS1633LL-750
• 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: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge
• Length: 750 Millimeter
• Needle Gauge: 16 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937020977 [Primary]
GS1	20888937020971 [Package]; Contains: 00888937020977; Package: Box [10 Units]; In Commercial Distribution
GS1	30888937020978 [Package]; Contains: 20888937020971; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012068

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)