Duns Number:001191048
Device Description: SureTrans Autotransfusion System for Orthopaedics with PVC Drain and 2 Trocars
Catalog Number
8590000
Brand Name
SureTrans Autotransfusion System for Orthopaedics
Version/Model Number
8590000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAC
Product Code Name
APPARATUS, AUTOTRANSFUSION
Public Device Record Key
fe9026e8-8299-4708-81d8-61d072b325f3
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
June 17, 2015
Package DI Number
10801741000390
Quantity per Package
6
Contains DI Package
00801741000393
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |