AccessGUDID - DEVICE: Wrist Assist Wrist Support (10815614020170)

GUDID

Device Identifier (DI) Information

Brand Name: Wrist Assist Wrist Support
Version or Model: 4300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 140-0300-00
Company Name: Semler Technologies, Inc.

Primary DI Number: 10815614020170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042075700 *Terms of Use

Device Description: The WristAssist Model 4300 is a wrist support device that extends the patient's wrist at a consistent 30° angle.

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":	Yes
For Single-Use:	Yes
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?
45128	Wrist immobilizer, single-use	A rigid external support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure (e.g., radial catheterization). The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMQ	Restraint, Protective

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: d6c0e8d8-7457-44d1-8236-4c09911e2a2f
Public Version Date: October 16, 2024
Public Version Number: 3
DI Record Publish Date: November 17, 2022