Duns Number:103977526
Device Description: Reusable non-sterile optical distance indicator for use with Iso-Align
Catalog Number
MTIAD16
Brand Name
O.D.I. Checking Tool
Version/Model Number
MTIAD16
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 02, 2017
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LHO
Product Code Name
Instrument, quality-assurance, radiologic
Public Device Record Key
f9399218-47d7-41ff-9872-2503103569f7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 02, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1027 |