Duns Number:027680821
Device Description: Intended provide surgeons and operating room staff a method for organizing and passing sur Intended provide surgeons and operating room staff a method for organizing and passing surgical instruments and/ or supplies safely and effectively.
Catalog Number
-
Brand Name
Aspen® Transfer System
Version/Model Number
ST-904NS
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
d8d1a8f2-f81a-4020-b0f4-bd79505b8b6d
Public Version Date
March 04, 2021
Public Version Number
3
DI Record Publish Date
May 14, 2019
Package DI Number
10887761006604
Quantity per Package
125
Contains DI Package
00887761006607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |