Programmable Automatic Biopsy System 14G X 9CM
ACHIEVE - BA149
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: 9 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
Device IdentifiersDevice Id: 50885403238053
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403238055
Package Quantity: 5
Package Discontinue Date: 11/30/2019 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case
Device Id: 10885403238055
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
Device Id: 20885403238052
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 50885403238053
Package Quantity: 12
Package Discontinue Date: 11/30/2019 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Box