Hummingbird®

Basic Information

• Brand Name: Hummingbird®
• Primary DI: 00851680007199
• Version / Model: STC
• Catalog Number: STC
• Company Name: INNERSPACE NEURO SOLUTIONS, INC.
• Labeler DUNS: 080333634
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-17
• Public Version: 4
• Public Version Date: 2021-02-09
• Public Version Status: Update
• Public Device Record Key: 94b36c57-5008-49b6-ae3d-0f65227f3a48
• Distribution End Date: 2019-03-19

Device Description

STC - Skull Thickness Caliper

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWM	Device, Monitoring, Intracranial Pressure	Neurology	882.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48167	General-purpose calliper, plastic	A non-sterile, manually-operated, lubricant free, plastic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of reinforced plastic that cannot be steam sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851680007199	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083378	000