Duns Number:316584937
Device Description: The seca 216 has a variable scale with a range of 3.5 to 230 centimeters that is inserted The seca 216 has a variable scale with a range of 3.5 to 230 centimeters that is inserted into a 138 cm frame. The plastic frame is simply mounted on the wall at the desired height. As the user can choose the range shown in the frame, the seca 216 is suitable for measuring children or adults. The results are clearly displayed in a window on the side of the rod and held in place by the locking screw on the head piece. Suitable for international use, the scale is printed in centimeters on one side of the tape and centimeters and inches on the other.
Catalog Number
2161814009
Brand Name
seca 216
Version/Model Number
216
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
FRW
Product Code Name
SCALE, PATIENT
Public Device Record Key
a71d1e60-a703-4d96-b00e-5934ba8ca27b
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| U | Unclassified | 3 |