Duns Number:080935429
Device Description: 7075 Staple Remover
Catalog Number
50007075
Brand Name
Devon
Version/Model Number
50007075
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
0a511a12-579b-4cf6-afc8-7e49c5c5d5e0
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 30, 2018
Package DI Number
10884527011629
Quantity per Package
96
Contains DI Package
30884527011623
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |