Duns Number:942377524
Device Description: TAP 3.5MM
Catalog Number
600740
Brand Name
Integra® Spider™ Limted Wrist Fusion System
Version/Model Number
600740
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"
-
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
HWX
Product Code Name
TAP, BONE
Public Device Record Key
4e2b07ca-b81b-4a5b-8803-c5f39d7917a4
Public Version Date
March 04, 2021
Public Version Number
2
DI Record Publish Date
April 24, 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 | 1909 |
2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
3 | A medical device with high risk that requires premarket approval | 12 |
U | Unclassified | 15 |