DynaRide S 2 Wheelchair-18"x16" Seat w/ Detach Full Arm ELR

GUDID 00616784022512

DYNAREX CORPORATION

Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

• Primary Device ID: 00616784022512
• NIH Device Record Key: dfff1be8-59a1-4082-83e4-e8a5db2e215c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaRide S 2 Wheelchair-18"x16" Seat w/ Detach Full Arm ELR
• Version Model Number: 10225
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00616784022512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070176

FDA Product Code

• IOR: Wheelchair, Mechanical

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: 2019-07-02
• Device Publish Date: 2019-06-24

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