PowrSyringe

GUDID B090PWR101

The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures.

ZIEN MEDICAL TECHNOLOGIES, INC.

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• Primary Device ID: B090PWR101
• NIH Device Record Key: 4f2449e2-f213-46eb-8355-97355ad268f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowrSyringe
• Version Model Number: PWR-10
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090PWR100 [Primary]
HIBCC	B090PWR101 [Package]; Contains: B090PWR100; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090PWR102 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072318

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: 2022-08-31
• Device Publish Date: 2022-08-23

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