Duns Number:078703080
Device Description: K-wire Ø1.3 x L100mm
Catalog Number
MDS001013100R
Brand Name
K-wire Ø1.3 x L100mm
Version/Model Number
MDS001013100R
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
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
bc506660-a9e1-49f1-987a-d7a0ce5b24bb
Public Version Date
January 17, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 464 |