Basic, Quick-Release Head Immobilizer

GUDID 00616784562926

Basic, Quick-Release Head Immobilizer, White

DYNAREX CORPORATION

Head/neck immobilizer, single-use

• Primary Device ID: 00616784562926
• NIH Device Record Key: cda954a4-7a54-4a9f-a66c-f89847c53544
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Basic, Quick-Release Head Immobilizer
• Version Model Number: 5629
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 5
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784562926 [Unit of Use]
GS1	00616784562933 [Primary]

FDA Product Code

• MRI: Orthosis, Truncal/Orthosis, Limb

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: 2021-09-09
• Device Publish Date: 2021-09-01

Devices Manufactured by DYNAREX CORPORATION

• 00616784356327 - Cloth Surgical Tape 2" x 10 yds: 2024-10-16
• 00616784356426 - Cloth Surgical Tape 3" x 10 yds: 2024-10-16
• 00616784357126 - Clear Surgical Tape 1/2"x10 Yds: 2024-10-16
• 00616784357225 - Clear Surgical Tape 1" x 10 yds: 2024-10-16
• 00616784357324 - Clear Surgical Tape 2" x 10 yds: 2024-10-16
• 00616784357423 - Clear Surgical Tape 3" x 10 yds: 2024-10-16
• 00616784358628 - CurPro Porous Tape, White, 1/2" x 10 yds: 2024-10-16
• 00616784358727 - CurPro Porous Tape,White,1" x 10 yds: 2024-10-16