Duns Number:009900424
Device Description: AccuFilm® II Booklet Red/Black (5 Booklets of 50)
Catalog Number
S053
Brand Name
AccuFilm®
Version/Model Number
Red/Black Booklet
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2019
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
EFH
Product Code Name
Paper, Articulation
Public Device Record Key
5ba1b819-15cb-482c-88bb-005a88a4f25d
Public Version Date
March 29, 2019
Public Version Number
2
DI Record Publish Date
October 12, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |