Duns Number:071426803
Device Description: Acu-Punch, 2.5mm, Single
Catalog Number
-
Brand Name
Acu-Punch
Version/Model Number
P2.5
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EME
Product Code Name
Punch, Biopsy, Surgical
Public Device Record Key
f55e4ccc-efd6-4dfc-bc82-af194674acdf
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
10814105020910
Quantity per Package
25
Contains DI Package
00814105020913
Package Discontinue Date
-
Package Status
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 | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |