AccessGUDID - DEVICE: M.A.S.S. Traction Belt (G505MRTB0)

GUDID

Device Identifier (DI) Information

Brand Name: M.A.S.S. Traction Belt
Version or Model: Standard
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.A.S.S. Rehab, LLC

Primary DI Number: G505MRTB0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 603101416 *Terms of Use

Device Description: 2-part belt for providing lumbar traction.

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?
46526	Traction system belt	A harness designed to provide traction to the lower spine, including the lumbar and pelvic areas, with force from an external traction system. It is typically a padded piece of material (e.g., cotton, vinyl) that is placed around the waist, and has one or more straps with rings at the end that permit its attachment to the traction system's cable. It may include additional rings for attachment to a spreader bar. The harness is used mainly for relief of low back pain and to maintain normal alignment of the vertebrae.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	Exerciser, Non-Measuring

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: d86c5559-c652-40c4-b0c6-a2e32d6dc2ba
Public Version Date: August 09, 2023
Public Version Number: 1
DI Record Publish Date: August 01, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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