Duns Number:316584937
Device Description: The measuring station seca 797 measures and weighs in a single step. seca 797 is equipped The measuring station seca 797 measures and weighs in a single step. seca 797 is equipped with an digital meauring rod.The scale has a maximum capacity of 250 kg and a graduation of 100 g. The measuring rod has a measuring range up to 230 cm and a graduation of 1 mm.Integration capability through WLAN technology.
Catalog Number
7971721009
Brand Name
seca 797
Version/Model Number
797
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRI
Product Code Name
SCALE, STAND-ON, PATIENT
Public Device Record Key
5068d778-232c-4850-ad18-0371fe099e7b
Public Version Date
September 10, 2019
Public Version Number
1
DI Record Publish Date
September 02, 2019
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| U | Unclassified | 3 |