Duns Number:961027315
Device Description: STRL CUSTOM THYROID DRAPE PACK
Catalog Number
SBA53TDISA
Brand Name
CARDINAL HEALTH
Version/Model Number
SBA53TDISA
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"
Yes
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
d0a55dde-30cd-4e33-81ac-b241504cd97b
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
November 20, 2017
Package DI Number
50887488850175
Quantity per Package
16
Contains DI Package
10887488850177
Package Discontinue Date
-
Package Status
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |