Duns Number:622768711
Device Description: Tube Inserter
Catalog Number
TI
Brand Name
Ahmed Tube Inserter
Version/Model Number
TI
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2022
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
HNR
Product Code Name
Forceps, ophthalmic
Public Device Record Key
e17835d8-ed05-4ba2-afb3-cbf42e84cd82
Public Version Date
October 05, 2022
Public Version Number
2
DI Record Publish Date
October 11, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 8 |