G-Vitri™ Vitrification Straw

GUDID 06976438303218

Gimbo Medical Technology Shenzhen Co., Ltd.

Tissue cryostorage straw

• Primary Device ID: 06976438303218
• NIH Device Record Key: 6c1062af-04b9-41ca-9396-7cecae8c7da0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-Vitri™ Vitrification Straw
• Version Model Number: SP-B-R
• Company DUNS: 722458269
• Company Name: Gimbo Medical Technology Shenzhen Co., Ltd.
• Device Count: 10
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06976438303065 [Unit of Use]
GS1	06976438303218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240002

FDA Product Code

• MQK: Labware, 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: 2024-07-03
• Device Publish Date: 2024-06-25

On-Brand Devices [G-Vitri™ Vitrification Straw]

• 06976438303294: SC-C-G
• 06976438303287: SC-C-O
• 06976438303270: SC-C-Y
• 06976438303263: SC-C-R
• 06976438303256: SC-C-B
• 06976438303249: SP-B-G
• 06976438303232: SP-B-O
• 06976438303225: SP-B-Y
• 06976438303218: SP-B-R
• 06976438303201: SP-B-B
• 06976438303195: SP-A-G
• 06976438303188: SP-A-O
• 06976438303171: SP-A-Y
• 06976438303164: SP-A-R
• 06976438303157: SP-A-B