Duns Number:341086190
Device Description: Titanium screw M 1.6 x 2.5 mm 10 Pieces
Catalog Number
33001161
Brand Name
Titanium screw M 1.6 x 2.5 mm
Version/Model Number
33001161
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBL
Product Code Name
PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS
Public Device Record Key
9926d85e-a29f-4167-a2c4-339eee996e5a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
EBRE330011619
Quantity per Package
1
Contains DI Package
EBRE330011610
Package Discontinue Date
September 22, 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 |