Duns Number:303655286
Device Description: The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is use The A.M.I. FasciaCutter Disposable Instrument is a sterile, disposable scalpel that is used to for enlargement of trocar incisions. The instrument is used in conjunction withan A.M.I. TissueBag for retrieval of specimen bags. The A.M.I. Fascia Cutter Disposable Instrument allows for easy removal of specimens in order to avoid risk of damaging the specimen bag while enlarging the trocar incision.
Catalog Number
AFC 100
Brand Name
A.M.I. FasciaCutter Disposable Instrument
Version/Model Number
AFC 100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 24, 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
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
FZT
Product Code Name
Cutter, Surgical
Public Device Record Key
fba0548c-9f1f-4f07-9d12-c189a721d334
Public Version Date
October 03, 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 |