RASP 1992208 FEATHERTOUCH 2PK COARSE
FeatherTouch® - 1992208
Device Description
A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
- Width: 8.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
- Moist Heat or Steam Sterilization
Product Codes
Code: HRX
Device Name: Arthroscope
Device Class: 2
Physical State: N/A
Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: OR
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: 888.1100
Third Party Flag: Y
Medical Specialty: OR
Device IdentifiersDevice Id: 20681490051525
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: 00681490051521
Device Type: Unit of Use
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