PMT® Halo Systems 1214-441

GUDID 00650551117285

HALO, CTLSO VEST X-LARGE, LAMBSWOOL LINER, 1211-1 MEDIUM OPEN BACK RING, 1206-33 HEADBLOCKS, 1206-11 TRACTION BAIL

PMT CORPORATION

Cervical spine immobilization system, single-use
Primary Device ID00650551117285
NIH Device Record Key9a4c2ac6-e3c9-408a-9799-1fcc09126752
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMT® Halo Systems
Version Model Number1214-441
Catalog Number1214-441
Company DUNS039576871
Company NamePMT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-626-5463
Emailinfo@pmtcorp.com
Phone800-626-5463
Emailinfo@pmtcorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
Storage Environment TemperatureBetween 58 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100650551117285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAXTong, Skull For Traction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-22

On-Brand Devices [PMT® Halo Systems]

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

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