AccessGUDID - DEVICE: Valmax (06974231101260)

GUDID

Device Identifier (DI) Information

Brand Name: Valmax
Version or Model: DME.004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Supply Line Medical

Primary DI Number: 06974231101260
Issuing Agency: GS1
Commercial Distribution End Date: January 21, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 117011784 *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?
67034	Manual traction wheelchair	A dedicated, non-powered, wheeled mobility device with a seat designed to enable occupant mobilization while facilitating spinal traction in conjunction with a skull-attached halo ring (not included) for a patient with a spinal disorder (e.g., kyphosis, scoliosis). It is designed as a push-rim wheelchair with rear-fitted handles, and a suspension frame with an overhead pulley(s) and a cable. Traction is achieved by forces from weights or springs applied to the cable connected to the halo ring. It is only intended for use in a healthcare facility, typically to stretch the spine prior to surgical correction.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOR	Wheelchair, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112816	000

Device Exempt from Premarket Submission: No 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: 943a650f-0817-4882-9641-bc06726ee968
Public Version Date: February 20, 2025
Public Version Number: 2
DI Record Publish Date: January 21, 2025

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES