Duns Number:078312999
Device Description: SCALE, STAND-ON, PATIENT. A stand-on patient scale is a device intended for medical purpos SCALE, STAND-ON, PATIENT. A stand-on patient scale is a device intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.
Catalog Number
-
Brand Name
Lark Technologies, Inc
Version/Model Number
GBS-2104-G
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)
Yes
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
af1f7ec7-ce80-4679-bc71-92f2c2d012e9
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
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 | 1 |