AccessGUDID - DEVICE: Span-America (H93340707)

GUDID

Device Identifier (DI) Information

Brand Name: Span-America
Version or Model: Geomattress
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40707
Company Name: SPAN-AMERICA MEDICAL SYSTEMS, INC.

Primary DI Number: H93340707
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073704413 *Terms of Use

Device Description: STRETCHER ULTRAMAX 76 X 30 X 4 H MODEL

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):	Yes
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?
63247	Surgical instrument guard, single-use	A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKY	Mattress, Flotation Therapy, Non-Powered

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: 5e31fdff-e881-478c-b82e-367b92c3e14f
Public Version Date: February 20, 2023
Public Version Number: 2
DI Record Publish Date: November 30, 2022