Duns Number:780318028
Device Description: Press form Sheets, Hard, 0.040
Catalog Number
-
Brand Name
Press form Sheets, Hard, 0.040
Version/Model Number
EPS1774
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
EBL
Product Code Name
PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS
Public Device Record Key
2e395db5-24dd-439d-b7a3-c7cef6a2f36c
Public Version Date
October 29, 2021
Public Version Number
4
DI Record Publish Date
September 21, 2016
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 154 |