Shifeng

GUDID G002011070

SHIFENG MEDICAL TECHNOLOGY CO.，LTD.

Hypodermic needle, single-use

• Primary Device ID: G002011070
• NIH Device Record Key: b33f0da4-4690-43c8-a680-5c1dc9a04df3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shifeng
• Version Model Number: 01-107
• 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	G002011070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132552

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: 2021-02-11
• Device Publish Date: 2021-02-03

On-Brand Devices [Shifeng]

• G002UU3LHN25100: UU3LHN2510
• G002UU3LHN23100: UU3LHN2310
• G002UU1SHN25100: UU1SHN2510
• G002UU1SHN23100: UU1SHN2310
• G002UU1180: UU118
• G002011070: 01-107
• G001ZSQ1W0: ZSQ1W
• G002SFA0123100: SFA012310
• G002UUSF3LL0: UUSF3LL
• G002UUSF2510SN0: UUSF2510SN
• G002UUSF1LL0: UUSF1LL
• G002UUSF2310SN0: UUSF2310SN
• G002UUSF1LHN23100: UUSF1LHN2310
• UUSF2231SN0: UUSF2231SN
• UUSF1LHN25100: UUSF1LHN2510
• G00210112251B0: 1011-2251B
• G002100360: 10036
• G002100350: 10035
• G002100170: 10017
• G002100630: 10063