Duns Number:007153505
Device Description: OIML EC Class III, 280kg x 0.1kg, Apex Series Scale, EU AC Adapter, BT/WiFi, Mech. Height OIML EC Class III, 280kg x 0.1kg, Apex Series Scale, EU AC Adapter, BT/WiFi, Mech. Height Rod
Catalog Number
-
Brand Name
Detecto
Version/Model Number
APEX-C-ACEU
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
0746031e-7b7f-4ba6-b824-0a9a414d5096
Public Version Date
February 04, 2022
Public Version Number
1
DI Record Publish Date
January 27, 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 | 252 |