AccessGUDID - DEVICE: CORE (04546540401939)

GUDID

Device Identifier (DI) Information

Brand Name: CORE
Version or Model: 5400015000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5400-015-000
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540401939
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Micro Drill

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):	Yes
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?
33541	Bone/joint surgical power tool motor, electric	A hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of non-dental surgical procedures such as drilling or sawing of bones and tough tissues. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50d53ceb-f01e-4733-91fa-9c12e11f74ab
Public Version Date: July 25, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016