TEMNO NEEDLE BIOPSY COAXIAL 14G X 20CM
TEMNO - CT1420
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
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FCG
Device Name: Biopsy Needle
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
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 IdentifiersDevice Id: 50885403089013
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403089015
Package Quantity: 5
Package Discontinue Date: 11/30/2019 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case
Device Id: 10885403089015
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