Duns Number:009900424
Device Description: AccuFilm® Arch Marking Paper- Red/Blue
Catalog Number
S050
Brand Name
AccuFilm®
Version/Model Number
Arch
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2021
Issuing Agency
In GS1
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
0b56e1c6-16af-4cc1-b923-210d832ef24a
Public Version Date
April 21, 2022
Public Version Number
2
DI Record Publish Date
October 19, 2018
Package DI Number
20810000526134
Quantity per Package
6
Contains DI Package
10810000526137
Package Discontinue Date
September 30, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| 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 |