Duns Number:389566209
Device Description: Titanium guide sleeve D5.6/d4.6/L4.0 for Astra Tech EV, ND-> For further information visi Titanium guide sleeve D5.6/d4.6/L4.0 for Astra Tech EV, ND-> For further information visit steco.de
Catalog Number
M.27.15.D460
Brand Name
StecoGuide
Version/Model Number
M.27.15.D460
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
1824ee30-0336-4e73-ba02-a11aeaa93e2c
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
May 01, 2018
Package DI Number
M2715D4602
Quantity per Package
5
Contains DI Package
ESTOM2715D4600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
foil pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |