Duns Number:199354556
Device Description: Self-Sealing Sterilization Pouches (Case has a different SKU number, i.e. 37151)
Catalog Number
-
Brand Name
PeelVue Pro
Version/Model Number
37149
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162258,K162258,K162258
Product Code
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
43c4c42c-8e6e-4d14-819e-0964946c07bc
Public Version Date
January 08, 2021
Public Version Number
1
DI Record Publish Date
December 31, 2020
Package DI Number
20615375011816
Quantity per Package
10
Contains DI Package
10615375011819
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |