AccessGUDID - DEVICE: Angled Ceiling Plate Add On Kit (00689281005302)

GUDID

Device Identifier (DI) Information

Brand Name: Angled Ceiling Plate Add On Kit
Version or Model: SP-ACP-AK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00530
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281005302
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The Angled Ceiling Plate (ACP) is a high quality, commercial grade installation accessory to be used with the SuperPole. The ACP is intended to angled. The ACP attaches to the top of the pole and is adjustable in angle from 0-45°. The ACP must be secured to ceiling joists with appropriate fasteners. The ACP is only to be used with HealthCraft’s SuperPole System. The ACP is not to be used with the SuperPole Bariatric, SuperPole Ultra and Ceiling Plate Extender. The ACP is not to be used in any other way than described above.

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: f8216146-2892-416d-badc-d2710f4c86d2
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021