Disposable High Pressure Syringe

GUDID 06970286900315

Union Medical Shenzhen Co.,LTD.

Angiographic syringe

• Primary Device ID: 06970286900315
• NIH Device Record Key: 50316501-1022-4599-a9c1-172937fff3f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable High Pressure Syringe
• Version Model Number: SMR101
• Company DUNS: 544445008
• Company Name: Union Medical Shenzhen 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970286900018 [Primary]
GS1	06970286900315 [Package]; Contains: 06970286900018; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170279

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2019-01-28
• Device Publish Date: 2018-12-26

On-Brand Devices [Disposable High Pressure Syringe]

• 06970286900438: SLF302
• 06970286900483: SEZ301
• 06970286900407: SLF108
• 06970286900391: SLF107
• 06970286900476: SEZ109
• 06970286900469: SEZ108
• 06970286900452: SEZ103
• 06970286900384: SLF103
• 06970286900445: SEZ101
• 06970286900421: SLF301
• 06970286900414: SLF202
• 06970286900360: SLF102
• 06970286900353: SLF101
• 06970286900377: SMR302
• 06970286900339: SMR301
• 06970286900322: SMR201
• 06970286900315: SMR101