Duns Number:149183167
Device Description: Specialty Anchor C Flexible And Straight Drivers With A/O Connection
Catalog Number
IS4550ANC
Brand Name
Anchor C
Version/Model Number
IS4550ANC
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
3b1798de-ab37-4a05-b93c-8cb183b62902
Public Version Date
March 27, 2020
Public Version Number
1
DI Record Publish Date
March 19, 2020
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 | 2688 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5304 |
| 3 | A medical device with high risk that requires premarket approval | 86 |