PMT® Halo Systems 1206-155

GUDID 00650551103349

HALO, 1203-5 VEST LARGE, ACRYLIC LINER, 1201-1 X-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W/ PEDIATRIC ANGLE BLOCKS

PMT CORPORATION

Cervical spine immobilization system, single-use

• Primary Device ID: 00650551103349
• NIH Device Record Key: df1e5562-25cb-4fb0-aa0c-b028a310b298
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMT® Halo Systems
• Version Model Number: 1206-155
• Catalog Number: 1206-155
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551103349 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-26

On-Brand Devices [PMT® Halo Systems]

• 00650551142423: HALO, 1203-5 VEST MEDIUM, ACRYLIC LINER, 1211-1 LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-1
• 00650551136873: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1201-1 XX-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS,
• 00650551136866: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1201-1 X-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W
• 00650551136859: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1201-1 LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W/
• 00650551136842: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1201-1 MEDIUM CLOSED BACK RING, 1206-25 HEADBLOCKS, W/
• 00650551136835: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1201-1 SMALL CLOSED BACK RING, 1206-25 HEADBLOCKS, W/
• 00650551136828: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1201-1 XX-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS,
• 00650551136811: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1201-1 X-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W
• 00650551136804: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1201-1 LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W/
• 00650551136798: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1201-1 MEDIUM CLOSED BACK RING, 1206-25 HEADBLOCKS, W/
• 00650551136781: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1201-1 SMALL CLOSED BACK RING, 1206-25 HEADBLOCKS, W/
• 00650551136774: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1201-1 XX-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS
• 00650551136767: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1201-1 X-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS,
• 00650551136750: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1201-1 LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W
• 00650551136743: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1201-1 MEDIUM CLOSED BACK RING, 1206-25 HEADBLOCKS,
• 00650551136736: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1201-1 SMALL CLOSED BACK RING, 1206-25 HEADBLOCKS, W
• 00650551136729: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-33 HEADBLOCKS, 120
• 00650551136712: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-32 HEADBLOCKS, 120
• 00650551136705: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 120
• 00650551136699: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 LARGE OPEN BACK RING, 1206-33 HEADBLOCKS, 1206-
• 00650551136682: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 LARGE OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-
• 00650551136675: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-
• 00650551136668: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 MEDIUM OPEN BACK RING, 1206-33 HEADBLOCKS, 1206
• 00650551136651: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 MEDIUM OPEN BACK RING, 1206-32 HEADBLOCKS, 1206
• 00650551136644: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 MEDIUM OPEN BACK RING, 1206-20 HEADBLOCKS, 1206
• 00650551136637: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 SMALL OPEN BACK RING, 1206-33 HEADBLOCKS, 1206-
• 00650551136620: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 SMALL OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-
• 00650551136613: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 SMALL OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-
• 00650551136606: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 X-SMALL OPEN BACK RING, 1206-33 HEADBLOCKS, 120
• 00650551136590: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 X-SMALL OPEN BACK RING, 1206-32 HEADBLOCKS, 120
• 00650551136583: HALO, 1203-9 VEST X-LARGE, COOLMAX LINER, 1211-1 X-SMALL OPEN BACK RING, 1206-20 HEADBLOCKS, 120
• 00650551136576: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-33 HEADBLOCKS, 120
• 00650551136569: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-32 HEADBLOCKS, 120
• 00650551136552: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 120
• 00650551136545: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 LARGE OPEN BACK RING, 1206-33 HEADBLOCKS, 1206-
• 00650551136538: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 LARGE OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-
• 00650551136521: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-
• 00650551136514: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 MEDIUM OPEN BACK RING, 1206-33 HEADBLOCKS, 1206
• 00650551136507: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 MEDIUM OPEN BACK RING, 1206-32 HEADBLOCKS, 1206
• 00650551136491: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 MEDIUM OPEN BACK RING, 1206-20 HEADBLOCKS, 1206
• 00650551136484: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 SMALL OPEN BACK RING, 1206-33 HEADBLOCKS, 1206-
• 00650551136477: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 SMALL OPEN BACK RING, 1206-32 HEADBLOCKS, 1206-
• 00650551136460: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 SMALL OPEN BACK RING, 1206-20 HEADBLOCKS, 1206-
• 00650551136453: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 X-SMALL OPEN BACK RING, 1206-33 HEADBLOCKS, 120
• 00650551136446: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 X-SMALL OPEN BACK RING, 1206-32 HEADBLOCKS, 120
• 00650551136439: HALO, 1203-9 VEST X-LARGE, ACRYLIC LINER, 1211-1 X-SMALL OPEN BACK RING, 1206-20 HEADBLOCKS, 120
• 00650551136422: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-33 HEADBLOCKS, 1
• 00650551136415: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-32 HEADBLOCKS, 1
• 00650551136408: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1211-1 X-LARGE OPEN BACK RING, 1206-20 HEADBLOCKS, 1
• 00650551136392: HALO, 1203-9 VEST X-LARGE, LAMBSWOOL LINER, 1211-1 LARGE OPEN BACK RING, 1206-33 HEADBLOCKS, 120