AccessGUDID - DEVICE: SuperPole in Shipping Tube (cut less than 90 in.) (00689281015967)

GUDID

Device Identifier (DI) Information

Brand Name: SuperPole in Shipping Tube (cut less than 90 in.)
Version or Model: SP-P-CUT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01596
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281015967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: Custom cut to length.The SuperPole is a high quality, commercial grade floor to ceiling safety pole. The SuperPole must be installed between a structural floor and ceiling by turning a jackscrew at the bottom of the pole. The pressure created by the jackscrew is strong enough for the SuperPole to support the user, yet it does not require drilling holes into the floor or ceiling. This is ideal for relocating or removing the pole. NOTE: The top plate has two holes that may be used to fix the plate directly to the ceiling joist if necessary. Do not install the pole where it is directly exposed to water.

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?
35586	Hand rail	A device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMR	Device, Transfer, Patient, Manual

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: 5233b806-f4ac-400c-9cdb-d03ea4b50866
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021