Duns Number:117630237
Device Description: Disposable Punch, 6.5 mm Pouch
Catalog Number
-
Brand Name
Disposable Punch, 6.5 mm
Version/Model Number
00-65P
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
LRY
Product Code Name
Punch, Surgical
Public Device Record Key
bc988075-5d10-4aab-be8f-c136d027d04d
Public Version Date
September 23, 2022
Public Version Number
1
DI Record Publish Date
September 15, 2022
Package DI Number
10818614022595
Quantity per Package
1
Contains DI Package
00818614022598
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 | 90 |
2 | A medical device with a moderate to high risk that requires special controls. | 162 |