Duns Number:874709348
Device Description: GERIATRIC RECLINER, W/SIDE GUARD PLATE, 3 POSITION, REAR LOCKING CASTERS. WEIGHT LIMIT: 25 GERIATRIC RECLINER, W/SIDE GUARD PLATE, 3 POSITION, REAR LOCKING CASTERS. WEIGHT LIMIT: 250 Lbs.
Catalog Number
-
Brand Name
DALTON GERIATRIC RECLINER
Version/Model Number
CW-D584
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 11, 2019
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRJ
Product Code Name
Chair, Geriatric
Public Device Record Key
2f9d0973-bb7c-44c2-b0e0-f2ad1b9b8148
Public Version Date
June 19, 2019
Public Version Number
1
DI Record Publish Date
June 11, 2019
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 | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 57 |