Duns Number:167102750
Device Description: Beesure Sterilization Pouch 200 /BAG , 3 1/2" x 10 1/2"
Catalog Number
-
Brand Name
Beesure
Version/Model Number
BE1231
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"
Yes
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
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
be344713-15a5-4235-b6c9-179df0ad7ba4
Public Version Date
June 21, 2022
Public Version Number
8
DI Record Publish Date
January 03, 2017
Package DI Number
20817508020027
Quantity per Package
10
Contains DI Package
10817508020020
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 | 8 |