AccessGUDID - DEVICE: MedSource Head Immobilizer Block (00840155408333)

GUDID

Device Identifier (DI) Information

Brand Name: MedSource Head Immobilizer Block
Version or Model: MS-91002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Not Applicable
Company Name: MEDSOURCE INTERNATIONAL LLC

Primary DI Number: 00840155408333
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041674552 *Terms of Use

Device Description: Head Immobilizer Blocks (2)

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?
45259	Head/neck immobilizer, single-use	A rigid or non-rigid, non-sterile, device usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. 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: 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: 9203e7f8-0f8e-4a73-a1de-c5edcb4d54c9
Public Version Date: July 30, 2021
Public Version Number: 1
DI Record Publish Date: July 22, 2021