Duns Number:303655286
Device Description: Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm.The Bluntdissect DLU`s a Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm.The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures.The system consists of:- various A.M.I.-dock Applicators, delivered non sterile,- various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
Catalog Number
A10 131
Brand Name
A.M.I.-dock Bluntdissect DLU 10mm
Version/Model Number
A10 131
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2020
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)
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
e05a9fd9-9cd5-45e9-a16e-6a2c4a805b63
Public Version Date
October 04, 2022
Public Version Number
2
DI Record Publish Date
November 28, 2018
Package DI Number
EAMIA101311
Quantity per Package
20
Contains DI Package
EAMIA101310
Package Discontinue Date
July 31, 2020
Package Status
Not in Commercial Distribution
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 |