Duns Number:022925151
Device Description: Sterilization Pouches 3.5” x 5.25” Self-Sealing Autoclave Bags with Indicators for Profess Sterilization Pouches 3.5” x 5.25” Self-Sealing Autoclave Bags with Indicators for Professional Surgical Instrument Cleaning Box of 200
Catalog Number
-
Brand Name
P&P Medical Surgical LLC
Version/Model Number
08600
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
KGY
Product Code Name
Bag, Intestine
Public Device Record Key
63ae3aaf-2058-448c-af9f-3022701b1c65
Public Version Date
February 21, 2022
Public Version Number
1
DI Record Publish Date
February 11, 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 |