Duns Number:832637081
Device Description: LOW PROF LCKNG SCREW F/IM NAIL Ø 5.0MM / L 100MM / XL25/ STE
Catalog Number
04045400TS
Brand Name
NA
Version/Model Number
04.045.400TS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K201336,K201346
Product Code
HSB
Product Code Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Public Device Record Key
ad26205f-5870-439a-932c-21d463f38f2d
Public Version Date
June 03, 2021
Public Version Number
1
DI Record Publish Date
May 26, 2021
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 |