HALO RING

GUDID 00650551106562

1211-1 OPEN BACK HALO RING, LARGE SHORT, INCLUDES (10) 3" SKULL PINS AND (3) POSITIONING PINS

PMT CORPORATION

Cervical spine immobilization system, single-use

• Primary Device ID: 00650551106562
• NIH Device Record Key: 622b31c4-21dc-4c7f-a95c-536ceadf2d6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HALO RING
• Version Model Number: 1211-1LS
• 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	00650551106562 [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 RING]

• 00650551106586: 1211-1 OPEN BACK HALO RING, MEDIUM SHORT, INCLUDES (10) 3" SKULL PINS AND (3) POSITIONING PINS
• 00650551106579: 1211-1 OPEN BACK HALO RING, X-LARGE SHORT, INCLUDES (10) 3" SKULL PINS AND (3) POSITIONING PINS
• 00650551106562: 1211-1 OPEN BACK HALO RING, LARGE SHORT, INCLUDES (10) 3" SKULL PINS AND (3) POSITIONING PINS
• 00650551106555: 1211-1 OPEN BACK HALO RING, X-SMALL SHORT, INCLUDES (10) 3" SKULL PINS AND (3) POSITIONING PINS
• 00650551106548: 1211-1 OPEN BACK HALO RING, XX-SMALL SHORT, INCLUDES (10) 3" SKULL PINS AND (3) POSITIONING PINS
• 00650551096252: 1211-1 OPEN BACK HALO RING, SMALL SHORT, INCLUDES (10) 3" SKULL PINS AND (3) POSITIONING PINS
• 00650551045069: OPEN BACK RING X-SMALL (4)3" PRESSURE PINS, (3)POSITIONING PINS
• 00650551045052: OPEN BACK RING XX-SMALL (4)3" PRESSURE PINS, (3)POSITIONING PINS
• 00650551042006: CLOSED BACK RING, X-SMALL, (10)2.5" SKULL PINS, (3)POSITIONING PINS
• 00650551004790: CLOSED BACK RING – LARGE, (5)3" SKULL PINS, (3)POSITIONING PINS, 90 PIN SITES
• 00650551004424: CLOSED BACK RING – MEDIUM, (5)3" SKULL PINS, (3)POSITIONING PINS, 90 PIN SITES