ACE Single Lumen Ovum Pickup Needle

GUDID 10812261016877

Ace Single Lumen Ovum Pickup Needle (17G,35cm)

ALLWIN MEDICAL DEVICES, INC.

IVF oocyte aspiration needle, single-use

• Primary Device ID: 10812261016877
• NIH Device Record Key: 54fb5855-e17d-402c-81fb-6c0dcb58a5bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE Single Lumen Ovum Pickup Needle
• Version Model Number: A-OVM-SL17/35
• Company DUNS: 796354509
• Company Name: ALLWIN MEDICAL DEVICES, 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: true
• 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

Customer Support Contacts

• Phone: 714-572-1709
• Email: info@allwinmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812261016870 [Primary]
GS1	10812261016877 [Package]; Contains: 00812261016870; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190590

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: 2020-04-17
• Device Publish Date: 2020-04-09

Devices Manufactured by ALLWIN MEDICAL DEVICES, INC.

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