Soft tissue gauge 6 mm

Basic Information

• Brand Name: Soft tissue gauge 6 mm
• Primary DI: 09321502027090
• Version / Model: 95070
• Catalog Number: 95070
• Company Name: Cochlear Bone Anchored Solutions AB
• Labeler DUNS: 559784736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-07
• Public Version: 5
• Public Version Date: 2025-11-04
• Public Version Status: Update
• Public Device Record Key: c215e53d-193b-48a2-9311-95f5ca3bf7f4

Device Description

N/A

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

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	09321502027090	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6 mm long gage
Length	6	Millimeter