AccessGUDID - DEVICE: Alumi-Hand PLUS (00810045921860)

GUDID

Device Identifier (DI) Information

Brand Name: Alumi-Hand PLUS
Version or Model: KH-860-Single
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KH-860-Single
Company Name: INSTRUMENT SPECIALISTS, INC.

Primary DI Number: 00810045921860
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041517095 *Terms of Use

Device Description: The Alumi-Hand PLUS is a ready to use STERILE Hand Immobilizer offering new ways of holding the digits unlike any other Hand Immobilizer on the market. Made of pliable aluminum and foam, lead free, latex free and X-ray compatible. Patent #

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?
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
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: Yes
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: 159a9f08-b4b5-4ecb-a576-a387e0889b23
Public Version Date: June 09, 2023
Public Version Number: 1
DI Record Publish Date: June 01, 2023