TEMNO NEEDLE BIOPSY COAXIAL 22G X 15CM

TEMNO NEEDLE BIOPSY COAXIAL 22G X 15CM
TEMNO - CT2215

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

Length: 15 Centimeter

Needle Gauge: 22 Gauge

Length: 15 Centimeter
Needle Gauge: 22 Gauge

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 Identifiers

Device Id: 50885403089235

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403089237

Package Quantity: 5

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

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10885403089237

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