Primary Device ID | 00092237623510 |
NIH Device Record Key | 0c0c4378-1f29-4bdc-9b43-805a6e1bc8cb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | THERADOT |
Version Model Number | DO1009PINLW |
Company DUNS | 827221698 |
Company Name | COMPASS HEALTH BRANDS CORP. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00092237623510 [Primary] |
IKD | Cable, Electrode |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-06-03 |
Device Publish Date | 2024-05-24 |
91813520010242 | THERADOT APPLICATOR LEADWIRE (2/PK) |
00092237623510 | THERADOT PIN LEADWIRE (2/PK) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERADOT 97840004 not registered Live/Pending |
Compass Health Brands Corp. 2023-03-15 |