Austin

Basic Information

• Brand Name: Austin
• Primary DI: 00866001000339
• Version / Model: Au-10-143S
• Catalog Number: Au-10-143S
• Company Name: AUSTIN MEDICAL
• Labeler DUNS: 010058700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-08
• Public Version: 1
• Public Version Date: 2018-07-09
• Public Version Status: New
• Public Device Record Key: 1d74285e-e023-4e05-925b-ba686b23db4a

Device Description

Total Capture Hysteroscopy Drape

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45021	Instrument/equipment drape, single-use, sterile	A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00866001000346	GS1	Case	8	In Commercial Distribution
Primary	00866001000339	GS1

Premarket Submissions

Submission Number	Supplement Number
K061422	000