Duns Number:303655286
Device Description: Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm.The A.M.I.- Handle and instrument for A.M.I. loading units for A.M.I.-dock Applicator 10mm.The A.M.I.-dock Applicator serves as endoscopic multiple use carrier to operate the A.M.I.-dock Disposable Loading Units (DLU).
Catalog Number
A10 112
Brand Name
A.M.I.-dock Applicator Short 10mm
Version/Model Number
A10 112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2022
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
-
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
GDO
Product Code Name
Applier, Surgical, Clip
Public Device Record Key
4d27ec75-4f04-4a33-95a3-a1251ba4389b
Public Version Date
October 04, 2022
Public Version Number
3
DI Record Publish Date
November 28, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |