Duns Number:022925151
Device Description: Disposable Probe Covers Lens Filters Made of Closed-Cell Foam Laminated with Sheet of High Disposable Probe Covers Lens Filters Made of Closed-Cell Foam Laminated with Sheet of High Density Polyethylene Plastic Film Fit Electronic Thermometer Box of 200
Catalog Number
-
Brand Name
P&P Medical Surgical LLC
Version/Model Number
02000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
ae039542-60c8-46d9-8dcf-71c536114d84
Public Version Date
February 18, 2022
Public Version Number
1
DI Record Publish Date
February 10, 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 | 53 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |