Duns Number:266062561
Device Description: Sliding 2D Loc 19x23 Perforated Paddle- Labelled
Catalog Number
-
Brand Name
Pristina Paddle
Version/Model Number
SLD 2D PF
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
K162268
Product Code
FMQ
Product Code Name
Restraint, protective
Public Device Record Key
402228e3-4e1c-498d-be1c-4ab41657ca76
Public Version Date
May 10, 2022
Public Version Number
1
DI Record Publish Date
May 02, 2022
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| 3 | A medical device with high risk that requires premarket approval | 5 |