AccessGUDID - DEVICE: CORE, Maestro (07613154284467)

GUDID

Brand Name: CORE, Maestro
Version or Model: 5400207000
Catalog Number: 5400207000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613154284467
Issuing Agency: GS1
Device Count: 1

Device Description: Non-exhausting Footpedal

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:	No
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Foot-switch, pneumatic	A gas-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g. a pneumatic surgical saw, pneumatic wire driver, pneumatic surgical power tool system control unit) to which it is connected typically via one or more hoses and which is dependent upon pressurized gas [e.g., medical air, nitrogen (N2)]. This is a reusable device.

Product Code	Product Code Name
HBB	MOTOR, DRILL, PNEUMATIC

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

Sterilization Method [?]
No Sterilization Methods Found

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

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(800)253-3210
Email: Inst.Stryker.cs@Stryker.com