Plackers-Grind No More

GUDID 00651080651516

Grind No More Disposable Dental Guards Up to 30 Uses 10ct. QWL46

RANIR, LLC

Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable Mouthguard, reusable
Primary Device ID00651080651516
NIH Device Record Keyb9fd81d8-ee02-435f-97fe-5f658abcf72a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlackers-Grind No More
Version Model Number78500 82744
Company DUNS364567615
Company NameRANIR, LLC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100651080651516 [Primary]
GS110651080651513 [Package]
Package: Inner [4 Units]
In Commercial Distribution
GS120651080651510 [Package]
Contains: 10651080651513
Package: Case [48 Units]
In Commercial Distribution
GS130651080651517 [Unit of Use]

FDA Product Code

OBRMouthguard, Over-The-Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-05
Device Publish Date2022-08-26

Devices Manufactured by RANIR, LLC

00651080651516 - Plackers-Grind No More2022-09-05Grind No More Disposable Dental Guards Up to 30 Uses 10ct. QWL46
00651080651516 - Plackers-Grind No More2022-09-05 Grind No More Disposable Dental Guards Up to 30 Uses 10ct. QWL46
10071031189528 - Rest Assured2021-10-25 Snore No More 89325AA
20651080000004 - Rest Assured2020-04-23 SNORE NO MORE 1CT

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