Duns Number:832637081
Device Description: 8MM TI SOLID TIBIAL NAIL 360MM-STERILE
Catalog Number
47836S
Brand Name
NA
Version/Model Number
478.36S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 04, 2019
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
K932330
Product Code
HSB
Product Code Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Public Device Record Key
aec48d29-ba08-4aec-82f9-3464ba3fe028
Public Version Date
March 04, 2019
Public Version Number
5
DI Record Publish Date
September 14, 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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |