AccessGUDID - DEVICE: Protective Mitt (M1435011101)

GUDID

Device Identifier (DI) Information

Brand Name: Protective Mitt
Version or Model: Protective Mitt with Stay Child
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50-1110
Company Name: Kenad SG Medical, Inc.

Primary DI Number: M1435011101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 626997381 *Terms of Use

Device Description: The Mitt is intended to be used to limit the movement of the patient's hands and fingers.

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:	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?
44851	Limb/torso/head restraint, single-use	A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. 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: 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: 3b6ab9cd-1bac-489a-b0a5-bdb89fdc283d
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 25, 2023