AccessGUDID - DEVICE: Hummingbird® (00851680007199)

GUDID

Device Identifier (DI) Information

Brand Name: Hummingbird®
Version or Model: STC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: STC
Company Name: INNERSPACE NEURO SOLUTIONS, INC.

Primary DI Number: 00851680007199
Issuing Agency: GS1
Commercial Distribution End Date: March 19, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 080333634 *Terms of Use

Device Description: STC - Skull Thickness Caliper

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, Monitoring, Intracranial Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083378	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 94b36c57-5008-49b6-ae3d-0f65227f3a48
Public Version Date: February 09, 2021
Public Version Number: 4
DI Record Publish Date: July 17, 2017