Duns Number:796416191
Device Description: 5.5/6.0 Screw Body Extension Caddy
Catalog Number
03-1750-1000
Brand Name
Response Spine System
Version/Model Number
03-1750-1000
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
a14eade0-b9d2-4d95-8e88-cc4b6653c563
Public Version Date
November 19, 2020
Public Version Number
1
DI Record Publish Date
November 11, 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 | 1662 |
2 | A medical device with a moderate to high risk that requires special controls. | 7273 |