Duns Number:341086190
Device Description: Bar patrix titanium without stud-head screw vks-sg 1.7 1 Piece
Catalog Number
4500SA17
Brand Name
Bar patrix titanium without
Version/Model Number
4500SA17
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 02, 2019
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
EGG
Product Code Name
ATTACHMENT, PRECISION, ALL
Public Device Record Key
50342f3b-c16b-497f-9445-b854c7293147
Public Version Date
April 03, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
EBRE4500SA179
Quantity per Package
1
Contains DI Package
EBRE4500SA170
Package Discontinue Date
September 21, 2016
Package Status
Not in Commercial Distribution
Package Type
dummy
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 375 |