Duns Number:109903521
Device Description: SPIDER2 SHOULDER STABILIZATION KIT
Catalog Number
72203833
Brand Name
NA
Version/Model Number
72203833
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
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
-
Product Code
FWZ
Product Code Name
Accessories, operating-room, table (kit)
Public Device Record Key
22238f57-c9d0-432d-b8a9-eb0a5010a92f
Public Version Date
November 03, 2020
Public Version Number
5
DI Record Publish Date
April 12, 2016
Package DI Number
20885554032189
Quantity per Package
12
Contains DI Package
00885554032185
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| 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 |