Duns Number:004324596
Device Description: UMF Medical FusionONE_ADA Model 3003-Power Hi-Lo Exam Table with Pneumatic Backrest, Seaml UMF Medical FusionONE_ADA Model 3003-Power Hi-Lo Exam Table with Pneumatic Backrest, Seamless Upholstered Top, Stirrups, Drain Pan, Electrical Receptacle, Drawer Warmer, Foot Control, Front Storage Drawer, Rear Reversible Storage Drawer - Available in 16 Colors
Catalog Number
-
Brand Name
UMF MEDICAL
Version/Model Number
3003
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
INQ
Product Code Name
Table, Powered
Public Device Record Key
036aeecb-d17c-4239-8ced-5e2d29f92bbf
Public Version Date
May 12, 2022
Public Version Number
2
DI Record Publish Date
March 15, 2021
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 | 155 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |