Duns Number:342243334
Device Description: Steinmann pin 3 Shank End, Diamond Point2.0mm/229mm, Sutur Passer 6 pcs./uni Steinmann pin 3 Shank End, Diamond Point2.0mm/229mm, Sutur Passer 6 pcs./unit
Catalog Number
KM71-880
Brand Name
Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer
Version/Model Number
KM71-880
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
7b1da25c-bec8-4069-9530-6974e944d2f5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 10, 2016
Package DI Number
EMAHKM718801
Quantity per Package
1
Contains DI Package
EMAHKM718800
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1976 |