Primary Device ID | 00860007686627 |
NIH Device Record Key | 85250637-956f-4bdc-941c-df0b16991bf6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Slow Wave |
Version Model Number | BROSA |
Company DUNS | 035177408 |
Company Name | Slow Wave, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860007686627 [Primary] |
MQC | Mouthguard, Prescription |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-02 |
Device Publish Date | 2025-09-24 |
00860007686610 | AT |
00860007686603 | DS8 |
00860007686627 | BROSA |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SLOW WAVE 97975622 not registered Live/Pending |
Slow Wave, Inc. 2021-11-30 |
![]() SLOW WAVE 97148354 not registered Live/Pending |
Slow Wave, Inc. 2021-11-30 |
![]() SLOW WAVE 90724281 not registered Live/Pending |
CoFactor, Inc. 2021-05-20 |
![]() SLOW WAVE 87935141 5711553 Live/Registered |
Young, Robert 2018-05-24 |