Duns Number:117630237
Device Description: Apollo Reusable Surgical Punch, 4.5mm
Catalog Number
-
Brand Name
Apollo
Version/Model Number
01-45P
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
-
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
2969ecff-d885-4198-a914-a359c20cf63b
Public Version Date
October 19, 2021
Public Version Number
3
DI Record Publish Date
August 04, 2020
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 | 90 |
2 | A medical device with a moderate to high risk that requires special controls. | 162 |