Skin Flap Gauge 7

Basic Information

• Brand Name: Skin Flap Gauge 7
• Primary DI: 09008738501562
• Version / Model: 50156
• Catalog Number: 10763-003
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-22
• Public Version: 5
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 047f9c69-5b17-4cf5-88cd-8d9f6d0da59e

Device Description

Reusable Surgical Tool

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64959	Skin flap thickness gauge	A hand-held manual surgical instrument intended to be used to evaluate the thickness of a skin flap to help determine its appropriate thickness prior to surgery (e.g., hearing implant surgery). It is in the form of a handle with a calibrated distal opening against which the skin flap is compared. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008738501562	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P990052	000