Primary Device ID | 00651080651516 |
NIH Device Record Key | b9fd81d8-ee02-435f-97fe-5f658abcf72a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Plackers-Grind No More |
Version Model Number | 78500 82744 |
Company DUNS | 364567615 |
Company Name | RANIR, LLC |
Device Count | 10 |
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 | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00651080651516 [Primary] |
GS1 | 10651080651513 [Package] Package: Inner [4 Units] In Commercial Distribution |
GS1 | 20651080651510 [Package] Contains: 10651080651513 Package: Case [48 Units] In Commercial Distribution |
GS1 | 30651080651517 [Unit of Use] |
OBR | Mouthguard, Over-The-Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-09-05 |
Device Publish Date | 2022-08-26 |
10651080651520 - Plackers | 2024-05-06 GRIND NO MORE 16 DENTAL GUARDS UP TO 48 USES QWL73 |
00651080651516 - Plackers-Grind No More | 2022-09-05Grind No More Disposable Dental Guards Up to 30 Uses 10ct. QWL46 |
00651080651516 - Plackers-Grind No More | 2022-09-05 Grind No More Disposable Dental Guards Up to 30 Uses 10ct. QWL46 |
10071031189528 - Rest Assured | 2021-10-25 Snore No More 89325AA |
20651080000004 - Rest Assured | 2020-04-23 SNORE NO MORE 1CT |