AccessGUDID - DEVICE: Hummer (04546540427885)

GUDID

Device Identifier (DI) Information

Brand Name: Hummer
Version or Model: 5290601100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5290-601-100
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540427885
Issuing Agency: GS1
Commercial Distribution End Date: August 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: 4 Handpiece

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:	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47859	Line-powered surgical power tool system motor	A compact line-powered engine (that may include a rechargeable battery) intended to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and tough tissues (e.g., cartilage, ligaments). It may be available in two different forms: 1) a pistol-like handpiece that connects to a variety of surgical power tool attachments; or 2) a proximal attachment (e.g., micro-motor) to a variety of motorless handpieces. The device may be cannulated to permit use of a guidewire. It may be operated with a hand- or foot-switch. This is a reusable device.	Obsolete	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 Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed05b2a6-6968-40a0-83dd-8dcb6e700ec9
Public Version Date: November 23, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2016