UU

GUDID G002UU1L0

SHIFENG MEDICAL TECHNOLOGY CO.，LTD.

General-purpose syringe, single-use

• Primary Device ID: G002UU1L0
• NIH Device Record Key: 168f6acb-b839-4343-ab0c-4298c247bdda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UU
• Version Model Number: UU1L
• 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	G002UU1L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132553

FDA Product Code

• FMF: Syringe, Piston

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: 2021-05-13
• Device Publish Date: 2021-05-05

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