Duns Number:656747172
Device Description: CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS)
Catalog Number
9903.0101.15S
Brand Name
CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)
Version/Model Number
9903.0101.15S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192310,K192310,K192310
Product Code
GXR
Product Code Name
Cover, Burr Hole
Public Device Record Key
ea4a5e4b-8dd6-460c-8140-bd466a0d57da
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
September 28, 2020
Package DI Number
14717002404172
Quantity per Package
4
Contains DI Package
04717002404175
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Delivery box