Duns Number:242049828
Device Description: Medical, surgical, dental orveterinary furniture HTS 9402.10.0000
Catalog Number
412016
Brand Name
Laguna Mist 30'' x 77'' 110V
Version/Model Number
412016
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 13, 2018
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"
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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
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
374894df-059f-4ea2-b8fd-98cc222122b7
Public Version Date
August 14, 2018
Public Version Number
3
DI Record Publish Date
July 18, 2017
Package DI Number
00667259000481
Quantity per Package
1
Contains DI Package
00667259000078
Package Discontinue Date
August 13, 2018
Package Status
Not in Commercial Distribution
Package Type
skid
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 52 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |