AccessGUDID - DEVICE: V Attachment for Traction Device (04946329251067)

GUDID

Device Identifier (DI) Information

Brand Name: V Attachment for Traction Device
Version or Model: 08-115-23-R2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08-115-23-R2
Company Name: MIZUHO CORPORATION

Primary DI Number: 04946329251067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690677802 *Terms of Use

Device Description: V Attachment Pin Type (R2)

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?
46511	Surgical traction tensioner	A hand-operated tensioning device designed to be attached to a patient-contact device (e.g., hand wrap/trap, pelvic bone pin, foot boot, skull tongs) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis), typically during orthopaedic procedures (e.g., cervical spine surgery, pelvic reconstruction, fracture reduction). It may be a floor-standing pole or attached to an operating table or table extension, and typically consists of a multi-jointed structure with metal bars/posts, a manual screw/crank for traction adjustment, and mounting clamps/adaptors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDC	Table, Operating-Room, Electrical

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
Length: 554 Millimeter

Device Record Status

Public Device Record Key: 0a491093-10dc-4530-8f59-62b55ac7633a
Public Version Date: July 13, 2022
Public Version Number: 1
DI Record Publish Date: July 05, 2022