Ear Pick Tip, Straight

Basic Information

• Brand Name: Ear Pick Tip, Straight
• Primary DI: 00385640000215
• Version / Model: PX-1000
• Catalog Number: PX-1000
• Company Name: Summit Medical, Inc.
• Labeler DUNS: 965484699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 4
• Public Version Date: 2021-08-23
• Public Version Status: Update
• Public Device Record Key: 92cb1009-8e9d-4e99-b551-4fcfed83b13e

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: Yes
• 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
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13039	Middle ear pick	A fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00385640000215	GS1
Package	10385640000212	GS1	Box	6	In Commercial Distribution

Customer Contacts

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