Duns Number:010209877
Device Description: Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 30 cc
Catalog Number
402-100U
Brand Name
SIENTRA Calf Implant
Version/Model Number
402-100U
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2022
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K974480
Product Code
MIB
Product Code Name
Elastomer, Silicone Block
Public Device Record Key
c624a7e9-6b65-4421-9cf1-1a33c1deca15
Public Version Date
June 13, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2015
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| 3 | A medical device with high risk that requires premarket approval | 549 |
| U | Unclassified | 312 |