Inrad

GUDID 10817295020791

PreciseCore Biopsy 18 ga x 5 cm 20 mm notch

Inrad

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 10817295020791
• NIH Device Record Key: e84424a2-5758-44b7-937b-ba42b5ea454f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inrad
• Version Model Number: 680518
• 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	00817295020794 [Primary]
GS1	10817295020791 [Package]; Contains: 00817295020794; 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

On-Brand Devices [Inrad]

• 10817295021071: Express Core Coaxial w/Hiliter 17 ga x 20 cm
• 10817295021064: Express Core Coaxial w/Hiliter 17 ga x 15 cm
• 10817295021057: Express Core Coaxial w/Hiliter 17 ga x 10 cm
• 10817295021040: UltraClip Coaxial w/Hiliter 16 ga x 10 cm
• 10817295021033: SelectCore Coaxial with Hiliter 19 ga x 20 cm
• 10817295021026: SelectCore Coaxial with Hiliter 17 ga x 20 cm
• 10817295021019: SelectCore Coaxial with Hiliter 15 ga x 20 cm
• 10817295021002: SelectCore Coaxial with Hiliter 19 ga x 15 cm
• 10817295020999: SelectCore Coaxial with Hiliter 17 ga x 15 cm
• 10817295020982: SelectCore Coaxial with Hiliter 15 ga x 15 cm
• 10817295020975: SelectCore Coaxial with Hiliter 13 ga x 15 cm
• 10817295020968: PreciseCore Coaxial w/Hiliter 19 ga x 10 cm (10mm)
• 10817295020951: PreciseCore Coaxial w/Hiliter 17 ga x 10 cm (10mm)
• 10817295020944: PreciseCore Coaxial w/Hiliter 13 ga x 10 cm (10mm)
• 10817295020937: AccuCore Coaxial w/Hiliter 19 ga x 15 cm
• 10817295020920: AccuCore Coaxial w/Hiliter 19 ga x 9 cm
• 10817295020913: AccuCore Coaxial w/Hiliter 17 ga x 15 cm
• 10817295020906: AccuCore Coaxial w/Hiliter 17 ga x 9 cm
• 10817295020890: AccuCore Coaxial w/Hiliter 15 ga x 15 cm
• 10817295020883: AccuCore Coaxial w/Hiliter 15 ga x 9 cm
• 10817295020876: AccuCore Coaxial w/Hiliter 13 ga x 15 cm
• 10817295020869: AccuCore Coaxial w/Hiliter 13 ga x 9 cm
• 10817295020852: PreciseCore Biopsy 20 ga x 15 cm 20 mm notch
• 10817295020845: PreciseCore Biopsy 18 ga x 15 cm 20 mm notch
• 10817295020838: PreciseCore Biopsy 20 ga x 10 cm 20 mm notch
• 10817295020821: PreciseCore Biopsy 18 ga x 10 cm 20 mm notch
• 10817295020807: PreciseCore Biopsy 20 ga x 5 cm 20 mm notch
• 10817295020791: PreciseCore Biopsy 18 ga x 5 cm 20 mm notch
• 10817295020784: PreciseCore Biopsy 14 ga x 5 cm 20 mm notch
• 10817295020777: PreciseCore Biopsy 20 gax 10 cm 10 mm notch
• 10817295020760: PreciseCore Biopsy 18 ga x 10 cm 10 mm notch
• 10817295020753: PreciseCore Biopsy 14 ga x 10 cm 10 mm notch
• 10817295020746: PreciseCore Biopsy 20 ga x 5 cm 10 mm notch
• 10817295020739: PreciseCore Biopsy 18 ga x 5 cm 10 mm notch
• 10817295020722: PreciseCore Biopsy 14 ga x 5 cm 10 mm notch
• 10817295020715: SelectCore Variable Throw Biopsy Device 20 ga x 20 cm
• 10817295020708: SelectCore Variable Throw Biopsy Device 18 ga x 20 cm
• 10817295020692: SelectCore Variable Throw Biopsy Device 16 ga x 20 cm
• 10817295020685: SelectCore Variable Throw Biopsy Device 20 ga x 15 cm
• 10817295020678: SelectCore Variable Throw Biopsy Device 18 ga x 15 cm
• 10817295020661: SelectCore Variable Throw Biopsy Device 14 ga x 15 cm
• 10817295020654: SelectCore Variable Throw Biopsy Device 16 ga x 15 cm
• 10817295020647: SelectCore Variable Throw Biopsy Device 20 ga x 10 cm
• 10817295020630: SelectCore Variable Throw Biopsy Device 18 ga x 10 cm
• 10817295020623: SelectCore Variable Throw Biopsy Device 16 ga x 10 cm
• 10817295020616: SelectCore Variable Throw Biopsy Device 14 ga x 10 cm
• 10817295020609: Modified Cournand Needle, 19 ga, 2 1/8"
• 10817295020593: Modified Cournand 2-part, 18 ga, 2 1/8"
• 10817295020555: IV Decanting Set
• 10817295020548: Arterial, 1-part, 19 ga x 2 3/4"