Oto Ease 93227

GUDID 20851809002962

Sterile Lubricant, Bottle

HR PHARMACEUTICALS INC.

General-body orifice lubricant, sterile

• Primary Device ID: 20851809002962
• NIH Device Record Key: 4cb11e24-31c5-44b5-9fb5-977eadd57650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oto Ease
• Version Model Number: 93227
• Catalog Number: 93227
• Company DUNS: 828918164
• Company Name: HR PHARMACEUTICALS INC.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(717)252-1110
• Email: chris.wiesman@hrpharma.com

Device Dimensions

• Weight: 15 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851809002968 [Primary]
GS1	20851809002962 [Package]; Contains: 00851809002968; Package: Case [250 Units]; In Commercial Distribution

FDA Product Code

• KMJ: Lubricant, patient

Sterilization

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

[20851809002962]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-27
• Device Publish Date: 2018-08-27

On-Brand Devices [Oto Ease]

• 20851809002986: Sterile Lubricant, Packet
• 20851809002979: Sterile Lubricant, Bottle
• 20851809002962: Sterile Lubricant, Bottle