Duns Number:832696038
Device Description: D-LOCK 35W SKIN STAPLER WIDE STRL 35CT
Catalog Number
89-8225
Brand Name
V. Mueller
Version/Model Number
89-8225
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2016
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
GDT
Product Code Name
STAPLE, REMOVABLE (SKIN)
Public Device Record Key
638eecde-98a5-4214-8112-bb1d93c64c97
Public Version Date
March 10, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
20885403273565
Quantity per Package
6
Contains DI Package
10885403273568
Package Discontinue Date
March 07, 2016
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 | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |