Duns Number:076649467
Device Description: Is composed of the Puregraft Easel and Puregraft Slider. Both components are made of autoc Is composed of the Puregraft Easel and Puregraft Slider. Both components are made of autoclavable stainless steel. The Easel holds the Puregraft Bag in place, and the Slider tool is used on the exterior of the Puregraft Bag to compress and facilitate the movement of liquids through the filter mesh and into the Drain Bag.
Catalog Number
-
Brand Name
Puregraft Instrument Set
Version/Model Number
550/IS SST
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
-
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
639467a4-6b0f-41e1-8680-4be75a9e4435
Public Version Date
February 17, 2022
Public Version Number
1
DI Record Publish Date
February 09, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |