Duns Number:931853006
Device Description: AN75.64 - Anprolene AN75 Sterilizer, 115V
Catalog Number
AN75.64
Brand Name
Anprolene AN75 Ethylene Oxide Sterilizer
Version/Model Number
AN75.64
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170432
Product Code
FLF
Product Code Name
Sterilizer, Ethylene-Oxide Gas
Public Device Record Key
f8606818-772a-444d-9fe2-72954ad49f1a
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 2020
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11 |