Duns Number:066689993
Device Description: BODYMED REPLACEMENT LEAD WIRES, 2/PK, for BODYMED TENS UNIT
Catalog Number
ZZA45LW
Brand Name
BodyMed
Version/Model Number
ZZA45LW
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
ce57c6b6-8a1d-4e53-86ff-6be1ca354a63
Public Version Date
February 27, 2020
Public Version Number
3
DI Record Publish Date
September 05, 2016
Package DI Number
20815802010119
Quantity per Package
500
Contains DI Package
00815802010115
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |