McKesson

Basic Information

• Brand Name: McKesson
• Primary DI: 20612479194995
• Version / Model: 16-157
• Company Name: MCKESSON MEDICAL-SURGICAL INC.
• Labeler DUNS: 023904428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2020-07-10
• Public Version: 1
• Public Version Date: 2020-07-20
• Public Version Status: New
• Public Device Record Key: 03012d1e-edb8-4ed9-9a91-aa6a34a6a4c9

Device Description

Otoscope Tips GRAY | DISPOSABLE 4.0mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
EPY	Speculum, Ent	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34897	Ear speculum, single-use	A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40612479195002	GS1	Case	10	In Commercial Distribution
Primary	20612479194995	GS1
Unit of Use	10612479236162	GS1