HALO TRAUMA KIT

GUDID 00650551003861

TRAUMA KIT, 1211-1S SMALL SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3" SKULL PINS, 1201-8 TORQUE DRIVER

PMT CORPORATION

Cervical spine immobilization system, single-use

• Primary Device ID: 00650551003861
• NIH Device Record Key: 172e2d58-25c1-4923-a383-8b748d24e225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALO TRAUMA KIT
• Version Model Number: 1211-6SS1
• 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: true
• 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	00650551003861 [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: true

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 TRAUMA KIT]

• 00650551106593: TRAUMA KIT, 1211-1MS MEDIUM SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3"
• 00650551004417: TRAUMA KIT, 1201-1B X-SMALL RING, 1206-25 HEADBLOCK FOR CLOSED BACK RING, 1206-11 TRACTION BAIL,
• 00650551003861: TRAUMA KIT, 1211-1S SMALL SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3" S