Duns Number:694721181
Device Description: AC 100 - 240 V, 79 - 102 VA, 50/60 Hz
Catalog Number
-
Brand Name
M200 Series (Ceiling, Mobile)
Version/Model Number
M200
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTD
Product Code Name
Lamp, Surgical
Public Device Record Key
d4fc6856-27cd-48d4-8691-d4f051a3c121
Public Version Date
May 26, 2021
Public Version Number
5
DI Record Publish Date
December 27, 2016
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 | 1118 |
2 | A medical device with a moderate to high risk that requires special controls. | 4011 |