AprioCore plus ACP16-095-20

GUDID 17350031350149

AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.

Apriomed AB

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 17350031350149
• NIH Device Record Key: 1722f447-582b-4ff6-b68c-f8e2bad06216
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AprioCore plus
• Version Model Number: ACP16-095-20
• Catalog Number: ACP16-095-20
• Company DUNS: 631734758
• Company Name: Apriomed AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: +46184301440
• Email: info@apriomed.com

Device Dimensions

• Needle Gauge: 16 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350031350142 [Primary]
GS1	17350031350149 [Package]; Contains: 07350031350142; Package: Shelf box [5 Units]; In Commercial Distribution
GS1	27350031350146 [Package]; Package: Transportation box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193268

FDA Product Code

• KNW: Instrument, Biopsy

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: 2020-03-31
• Device Publish Date: 2020-03-23

On-Brand Devices [AprioCore plus]

• 17350031350163: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350156: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350149: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350132: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350125: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350118: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350101: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350095: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350088: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350071: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350064: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
• 17350031350057: AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.