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
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
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