Duns Number:832575364
Device Description: The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to provide su The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to provide surgeon aid in transecting nerve tissue for the purpose of nerve graft preparation, nerve repair, or removal of exposed nerve. The kit includes three circumferential nerve constraining forceps, two blades, and a silicone visibility background.
Catalog Number
9250
Brand Name
Checkpoint Edge Nerve Cutting Kit
Version/Model Number
9250
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
HAO
Product Code Name
Instrument, Surgical, Non-Powered
Public Device Record Key
b4bf186e-15ce-4236-959a-2d12cefc9f66
Public Version Date
May 17, 2022
Public Version Number
1
DI Record Publish Date
May 09, 2022
Package DI Number
B13092501
Quantity per Package
1
Contains DI Package
B13092500
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pouch