- Physicians Office Resource

ACHIEVE NEEDLE BIOP SO TIS 14GX20CM COAX
ACHIEVE - CA1420

Device Description

A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Needle Gauge: 14 Gauge

Length: 20 Centimeter

Needle Gauge: 14 Gauge
Length: 20 Centimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KNW

Device Name: Instrument, Biopsy

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.1075

Third Party Flag: Y

Medical Specialty: GU

Code: GDF

Device Name: Guide, Needle, Surgical

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4800

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 50885403088634

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403088636

Package Quantity: 5

Package Discontinue Date: 11/30/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10885403088636

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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