Duns Number:315919220
Device Description: Guid wire drill ø 3.2 mm
Catalog Number
900307
Brand Name
EBERLE
Version/Model Number
900307
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
-
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
LHX
Product Code Name
Trousers, anti-shock
Public Device Record Key
fe570c45-bbbc-427e-ba26-8ba3a44c4b08
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
April 27, 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. | 106 |