Duns Number:173770868
Device Description: Rotating Surgical Punches, 1 per pouch
Catalog Number
-
Brand Name
A&E Medical / Rotating Surgical Punches
Version/Model Number
080-451
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
LRY
Product Code Name
Punch, Surgical
Public Device Record Key
d09f695b-2dd9-42cc-bcb5-92e5a2ab12d6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 01, 2016
Package DI Number
20841291105203
Quantity per Package
6
Contains DI Package
10841291105206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 621 |