ROHO HIGH PROFILE Dual Compartment Cushion

GUDID 00613732006846

Roho, Inc.

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• Primary Device ID: 00613732006846
• NIH Device Record Key: 86b7c11f-c892-4fab-8640-0406abadbfb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROHO HIGH PROFILE Dual Compartment Cushion
• Version Model Number: 2RSMC
• Company DUNS: 006614792
• Company Name: Roho, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613732006846 [Primary]

FDA Product Code

• KIC: Cushion, Flotation

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: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [ROHO HIGH PROFILE Dual Compartment Cushion]

• 00613732093143: 2R1012C
• 00613732008161: 2R99C
• 00613732008086: 2R98C
• 00613732008024: 2R911C
• 00613732007942: 2R910C
• 00613732007836: 2R89C
• 00613732007720: 2R88C
• 00613732007256: 2R119C
• 00613732007188: 2R1110C
• 00613732007096: 2R109C
• 00613732006983: 2R1011C
• 00613732006938: 2R1010C
• 00613732006846: 2RSMC
• 00613732006761: 2RLGC