Duns Number:794519020
Device Description: Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Sterile Fluid Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Sterile Fluid Path.
Catalog Number
4R2440
Brand Name
Apheresis Needle with MASTERGUARD™ Protector
Version/Model Number
4R2440
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 2020
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
-
Product Code
FIE
Product Code Name
Needle, Fistula
Public Device Record Key
cc6ba833-e0f1-431e-8ccd-c8dd5cdcbb2b
Public Version Date
July 10, 2020
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
10811137012432
Quantity per Package
250
Contains DI Package
00811137012435
Package Discontinue Date
June 09, 2020
Package Status
Not 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |