Duns Number:252468293
Device Description: The Ceiling Plate Extender (CPE) is a high quality, commercial grade installation accessor The Ceiling Plate Extender (CPE) is a high quality, commercial grade installation accessory to be used with the SuperPole. The CPE is intended to increase the top plate span of the SuperPole from 20-30" / 508-762mm. It can be used when the SuperPole is expected to be subjected to more aggressive use, or where structural ceiling joists have increase spacing (such as 24"/610mm between centers). The CPE is only to be used with HealthCraft’s SuperPole System. The CPE is not to be used with the Angled Ceiling Plate.
Catalog Number
01588
Brand Name
Ceiling Plate Extender™
Version/Model Number
SP-CPE
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"
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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
faa94d53-4092-4efc-8d0f-c0c275f90c05
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 |