Duns Number:041546137
Device Description: LRI Gauge, With Atraumatic Fixation Teeth, 13.00/19.00 mm Diameters, Length 134 mm, Titani LRI Gauge, With Atraumatic Fixation Teeth, 13.00/19.00 mm Diameters, Length 134 mm, Titanium
Catalog Number
2-031T
Brand Name
Rumex
Version/Model Number
2-031T
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
HLN
Product Code Name
Gauge, Lens, Ophthalmic
Public Device Record Key
47f86e6a-461c-4abf-a549-599274de494c
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 29, 2020
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 | 834 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |