FUTURE GENERATION MEDICAL

GUDID G002FUSF2510SN0

SHIFENG MEDICAL TECHNOLOGY CO.，LTD.

Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use

• Primary Device ID: G002FUSF2510SN0
• NIH Device Record Key: af75989f-39ab-4da4-ac8b-87a9b62d082b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUTURE GENERATION MEDICAL
• Version Model Number: FUSF2510SN
• Company DUNS: 554525197
• Company Name: SHIFENG MEDICAL TECHNOLOGY CO.，LTD.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G002FUSF2510SN0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142765

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

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: 2021-03-08
• Device Publish Date: 2021-02-27

Devices Manufactured by SHIFENG MEDICAL TECHNOLOGY CO.，LTD.

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• HSB107200 - House brand: 2022-04-25
• HSB107114 - House brand: 2022-04-18
• G002100170 - Shifeng: 2021-10-04
• G002100350 - Shifeng: 2021-10-04