AccessGUDID - DEVICE: CORD, NYLON TRACTION, 100/FT (00842430112713)

GUDID

Device Identifier (DI) Information

Brand Name: CORD, NYLON TRACTION, 100/FT
Version or Model: 346
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 346
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430112713
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?
62664	Traction cord	A length of synthetic fibre (e.g., nylon) intended to be used with a system of rope and pulleys, or a bed traction system, to apply traction forces during medical procedures (e.g., orthopaedic surgery, physical therapy). It is typically intended to be cut to the desired length, threaded around pulleys, and knotted where needed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HST	Apparatus, Traction, Non-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: 1a466e2b-42bf-40b5-8243-53e641ca30df
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020