Duns Number:040729840
Device Description: BACKBITER PUNCH STRAIGHT BITE QUICK CLICK INSERT
Catalog Number
1272-527SIN
Brand Name
BACKBITER PUNCH BITE
Version/Model Number
1272-527SIN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 15, 2020
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
c7c1d031-dd3b-47eb-a221-7755fc9e3a90
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
September 11, 2018
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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |