AccessGUDID - DEVICE: Pad Skytron 3100 2 Thick (2/St) (B337BB31001)

GUDID

Device Identifier (DI) Information

Brand Name: Pad Skytron 3100 2 Thick (2/St)
Version or Model: BB3100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB3100
Company Name: FUTURE HEALTH CONCEPTS, INC.

Primary DI Number: B337BB31001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037304144 *Terms of Use

Device Description: 3100 Operating Room Table Pad 2 Thick (Set Of 2). 2860 High Density Foam Non-Latex With 'Lectrolite Conductive Covering. With Velcro Kit

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?
36063	Stretcher mattress	A large, flat, cushion or pad with a strong cover filled with a resilient material (e.g., foam rubber) designed to be used on a stretcher to provide patient comfort whilst they lie upon it. It is much thinner than a bed mattress and is placed on top of, and typically secured to, the stretcher support platform covering this area. This is a general-purpose device that has no special therapeutic purpose.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWG	Surgical Table Cushion

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: 8c6489c2-c98f-439b-87d6-e38ccefa00a9
Public Version Date: September 18, 2020
Public Version Number: 1
DI Record Publish Date: September 10, 2020