Duns Number:109903521
Device Description: MICRORAPTOR KNOTLESS SA PEEK
Catalog Number
72205021
Brand Name
MICRORAPTOR
Version/Model Number
72205021
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
K181746
Product Code
MBI
Product Code Name
Fastener, fixation, nondegradable, soft tissue
Public Device Record Key
7143fee4-fb03-47e9-9551-8840f38b0f1d
Public Version Date
January 31, 2022
Public Version Number
1
DI Record Publish Date
January 21, 2022
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 | 10651 |
2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
3 | A medical device with high risk that requires premarket approval | 351 |