Duns Number:007153505
Device Description: PORTABLE APEX SCALE, WIRELESS, NON-MEDICAL AC ADAPTER
Catalog Number
-
Brand Name
Detecto
Version/Model Number
APEX-RI-WI-AC
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
FRI
Product Code Name
Scale, Stand-On, Patient
Public Device Record Key
af19d2a4-d4d1-4819-8ab2-f8e60eb4fecd
Public Version Date
March 05, 2020
Public Version Number
1
DI Record Publish Date
February 26, 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 | 252 |