HALO SYSTEM COMPONENT

GUDID 00650551098393

RING/BLOCK ATTACH HARDWARE SET: (4) SHCS, (4)WASHER, (1)ALLEN WRENCH FOR CLOSED BACK RINGS

PMT CORPORATION

Cervical spine immobilization system, single-use

• Primary Device ID: 00650551098393
• NIH Device Record Key: 75529e2f-55b8-4448-96be-dca95b355df4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALO SYSTEM COMPONENT
• Version Model Number: 1201-37
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551098393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090733

FDA Product Code

• HAX: Tong, Skull For Traction

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: 2025-03-18
• Device Publish Date: 2025-03-10

On-Brand Devices [HALO SYSTEM COMPONENT]

• 00650551117063: BRASS POSITIONING PIN FOR 1208-1 HALO RINGS
• 00650551098393: RING/BLOCK ATTACH HARDWARE SET: (4) SHCS, (4)WASHER, (1)ALLEN WRENCH FOR CLOSED BACK RINGS
• 00650551093923: (1) 2.5" PRESSURE SKULL PIN, STERILE, FOR USE WITH 1208-1 RING ONLY