Plackers

GUDID 10651080651520

GRIND NO MORE 16 DENTAL GUARDS UP TO 48 USES QWL73

RANIR, LLC

Mouthguard, reusable

• Primary Device ID: 10651080651520
• NIH Device Record Key: fa653204-162f-48c4-91e2-2ed37fa8a1c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plackers
• Version Model Number: 78501
• Company DUNS: 364567615
• Company Name: RANIR, LLC
• Device Count: 16
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00651080651523 [Primary]
GS1	10651080651520 [Package]; Contains: 00651080651523; Package: Inner [4 Units]; In Commercial Distribution
GS1	20651080651527 [Package]; Package: Shipper [48 Units]; In Commercial Distribution
GS1	50651080651528 [Unit of Use]

FDA Product Code

• OBR: Mouthguard, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-06
• Device Publish Date: 2024-04-26

Devices Manufactured by RANIR, LLC

• 10651080651520 - Plackers: 2024-05-06GRIND NO MORE 16 DENTAL GUARDS UP TO 48 USES QWL73
• 10651080651520 - Plackers: 2024-05-06 GRIND NO MORE 16 DENTAL GUARDS UP TO 48 USES QWL73
• 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