Duns Number:968623467
Device Description: Steerable Sheath, 8 French
Catalog Number
10876-001
Brand Name
Greatbatch Steerable Sheath
Version/Model Number
10876-001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
408b29d2-f1ec-4f85-9dd5-bb4166508ffd
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
October 19, 2017
Package DI Number
10821329000413
Quantity per Package
1
Contains DI Package
00821329000416
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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. | 275 |
| 3 | A medical device with high risk that requires premarket approval | 68 |