AccessGUDID - DEVICE: NA (07613327289886)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 5450800040
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5450-800-040
Company Name: STRYKER MEDTECH K.K.

Primary DI Number: 07613327289886
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 690682147 *Terms of Use

Device Description: Lock Wrench

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?
44778	Soft-tissue ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter: 6.5 Millimeter

Device Record Status

Public Device Record Key: 48b92216-9f94-45f9-9a6b-4be2b3a41b80
Public Version Date: August 02, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016