Duns Number:211167885
Device Description: Lockdown (LSSS) Surgical Instrument Metal Tray Lid. This Tray lid attaches to the Lockdown Lockdown (LSSS) Surgical Instrument Metal Tray Lid. This Tray lid attaches to the Lockdown Tray base (DI NO#: 05060433600845). This lid is supplied by Rudischhauser.
Catalog Number
RM06005
Brand Name
LSSS
Version/Model Number
RM06005
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
8050d5ab-2161-4692-a584-442f602650ba
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 |