House Brand Dentistry

GUDID G002HSB107119

SHIFENG MEDICAL TECHNOLOGY CO.，LTD.

General-purpose syringe, single-use

• Primary Device ID: G002HSB107119
• NIH Device Record Key: 19c0106d-bebe-4947-bbc1-135816eef9fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: House Brand Dentistry
• Version Model Number: HSB-107119
• 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	G002HSB107119 [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: 2023-10-03
• Device Publish Date: 2023-09-25

Devices Manufactured by SHIFENG MEDICAL TECHNOLOGY CO.，LTD.

• G002100640 - EZ: 2024-11-07
• G002100620 - EZ: 2024-11-05
• G002HSB107119 - House Brand Dentistry: 2023-10-03
• G002HSB107119 - House Brand Dentistry: 2023-10-03
• G002HSB107110 - House brand: 2023-05-18
• G002RG30 - RG3: 2022-08-01
• G002100630 - Shifeng: 2022-05-09
• HSB107200 - House brand: 2022-04-25
• HSB107114 - House brand: 2022-04-18