Duns Number:252468293
Device Description: The Angled Ceiling Plate (ACP) is a high quality, commercial grade installation accessory 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.
Catalog Number
00530
Brand Name
Angled Ceiling Plate Add On Kit
Version/Model Number
SP-ACP-AK
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMR
Product Code Name
Device, Transfer, Patient, Manual
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 298 |