AccessGUDID - DEVICE: CRANK HANDLE W/TORQUE LIMITER (00842430110191)

GUDID

Device Identifier (DI) Information

Brand Name: CRANK HANDLE W/TORQUE LIMITER
Version or Model: 5319-6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5319-6
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430110191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084527241 *Terms of Use

Device Description: No description.

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):	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?
62890	Operating table handcrank	A manually-operated mechanical device intended to be used to enable operation and adjustment of an operating table and its associated devices, including table tops, patient positioners, and positioning pads. It may be employed in normal operation or as backup when the electrical system and/or motors of an operating table have failed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: f8d1dff9-92c0-4c5d-9fa5-b568e42ba35d
Public Version Date: July 01, 2019
Public Version Number: 1
DI Record Publish Date: June 21, 2019