Biopsy Device
PreciseCore - 0902015000
Device Description
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Distal Length: 15.0 Centimeter
- Neck Length: 20.0 Millimeter
- Needle Gauge: 20.0 Gauge
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: 37613252722350
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 07613252722359
Package Quantity: 5
Package Discontinue Date: 1/5/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: pack
Device Id: 07613252722359
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