AccessGUDID - DEVICE: Techno-Aide (G242SB02RBLKST9)

GUDID

Device Identifier (DI) Information

Brand Name: Techno-Aide
Version or Model: SB-02R-BLK-ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB-02R-BLK-ST
Company Name: Techno-Aide, Inc.

Primary DI Number: G242SB02RBLKST9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 843929279 *Terms of Use

Device Description: SANDBAG: 2LB/4 X 9 - BLACK

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?
62663	Traction weight	A device in the form of a filled bag intended to be used with a system of rope and pulleys, or a bed traction system, to apply traction forces by means of gravity during medical procedures (e.g., orthopaedic surgery, physical therapy). It is typically filled with sand or steel shot, and may include hangers. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCX	SUPPORT, PATIENT POSITION

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: d73499d5-917d-4c67-80ef-a4eb668d69ae
Public Version Date: February 20, 2023
Public Version Number: 1
DI Record Publish Date: February 10, 2023