Inad

GUDID 10817295020814

PreciseCore Biopsy 14 ga x 10 cm 20 mm notch

Inrad

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 10817295020814
• NIH Device Record Key: 272e9db6-64e3-4bc5-ae2f-4abe3f0dac47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inad
• Version Model Number: 681014
• Company DUNS: 940023385
• Company Name: Inrad
• 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

Customer Support Contacts

• Phone: 6163017800
• Email: sales@inradinc.com
• Phone: 6163017800
• Email: sales@inradinc.com
• Phone: 6163017800
• Email: sales@inradinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817295020817 [Primary]
GS1	10817295020814 [Package]; Contains: 00817295020817; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093399

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-12-01

Devices Manufactured by Inrad

• 10817295020616 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 14 ga x 10 cm
• 10817295020623 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 16 ga x 10 cm
• 10817295020630 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 18 ga x 10 cm
• 10817295020647 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 20 ga x 10 cm
• 10817295020654 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 16 ga x 15 cm
• 10817295020661 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 14 ga x 15 cm
• 10817295020678 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 18 ga x 15 cm
• 10817295020685 - Inrad: 2019-07-12 SelectCore Variable Throw Biopsy Device 20 ga x 15 cm