Duns Number:007941230
Device Description: Punch Biopsy Dermal Stainless Steel Polystyrene 3 Millimeter Sterile Not Made With Natural Punch Biopsy Dermal Stainless Steel Polystyrene 3 Millimeter Sterile Not Made With Natural Rubber Latex Halyard
Catalog Number
-
Brand Name
Halyard
Version/Model Number
DP0300
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"
Yes
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
1de9945b-6b1c-45ba-b2cb-e5e17e97b12b
Public Version Date
March 31, 2022
Public Version Number
1
DI Record Publish Date
March 23, 2022
Package DI Number
20885632351195
Quantity per Package
25
Contains DI Package
10885632351198
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |