Duns Number:058311945
Device Description: Half Dose Bone Cement, 10 pack catalog number is 6188-1-010
Catalog Number
6188-1-001
Brand Name
Simplex
Version/Model Number
6188-1-001
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
K062553,K062553,K062553
Product Code
LOD
Product Code Name
BONE CEMENT
Public Device Record Key
86e02820-f2ee-4bf9-808a-f5f187b6d6d9
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
57613327128432
Quantity per Package
2
Contains DI Package
37613327128438
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 | 5091 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10216 |
| 3 | A medical device with high risk that requires premarket approval | 32 |