Duns Number:312546955
Device Description: K-Wire 2.5 x 200 mm Trocar point threaded round shaft
Catalog Number
27-00925-200-G
Brand Name
MONDEAL
Version/Model Number
27-00925-200-G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2020
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"
Yes
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
HTY
Product Code Name
PIN, FIXATION, SMOOTH
Public Device Record Key
e08078b0-f3ff-4e39-9c60-6aecf54d5506
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
June 26, 2017
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 565 |