Duns Number:211167885
Device Description: LOCKDOWN (LSSS) SURGICAL TRAY BASE WHICH HOUSES ALL INSTRUMENTS REQUIRED FOR THE LOCKDOWN LOCKDOWN (LSSS) SURGICAL TRAY BASE WHICH HOUSES ALL INSTRUMENTS REQUIRED FOR THE LOCKDOWN SHOULDER STABILISATION PROCEDURE. tHIS TRAY ALSO HAS A LID (DI NO#: 05060433600920) ASSOCIATED WITH IT THAT LOCKS INTO PLACE. TRAY BASE SUPPLIED BY RUDISCHHAUSER.
Catalog Number
RM04953
Brand Name
LSSS
Version/Model Number
RM04953
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)
-
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
c18fe4e2-d7cc-458c-91cd-8bf38974af67
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
July 24, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |