PMT® CORPORATION HALO 1201-17X4

GUDID 00650551093282

SUPERSTRUCTURE, INCLUDES: 1206-33 HEADBLOCK, 1201-18X 20" RODS, 1201-19 CHESTBLOCKS

PMT CORPORATION

Cervical spine immobilization system, single-use
Primary Device ID00650551093282
NIH Device Record Keyf3fda740-24b9-43bc-b614-28c01747ed12
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMT® CORPORATION HALO
Version Model Number1201-17X4
Catalog Number1201-17X4
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
GS100650551093282 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-10

On-Brand Devices [PMT® CORPORATION HALO]

00650551045830TRACTION BAIL WITH HEADBLOCK ATTACHMENT HARDWARE
00650551045144TITANIUM "S" HOOK
00650551045120TRACTION TONG, MEDIUM, WITH (2) 3" PRESSURE PINS
00650551045113TRACTION TONG, SMALL, WITH (2) 2.5" PRESSURE PINS
006505510451061208-1 OPEN BACK HALO RING, X-LARGE, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PIN
006505510450901208-1 OPEN BACK HALO RING, SMALL, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PINS
006505510450831208-1 OPEN BACK HALO RING, MEDIUM, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PINS
006505510450761208-1 OPEN BACK HALO RING, LARGE, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PINS
00650551045007TRACTION BAIL
00650551044994POSTERIOR BED ADAPTER, FOR MAYFIELD RADIOLUCENT
00650551044987ANTERIOR BED ADAPTER, FOR MAYFIELD RADIOLUCENT
00650551044970SURGICAL BED ADAPTER, ANTERIOR & POSTERIOR
00650551044963SURGICAL BED ADAPTER, POSTERIOR
00650551044956SURGICAL BED ADAPTER, ANTERIOR
00650551044949TORQUE DRIVER
00650551044932PRECISION TORQUE DRIVER
00650551044925HEADHOLDER, FOR ATTACHING OPEN BACK RINGS
00650551044918DOUBLE ENDED TORQUE DRIVER BIT, FOR 1201-8 TORQUE WRENCH
00650551044901WRENCH SET: 2 ALLEN WRENCHS & 1 COMBO WRENCH
00650551044895SHOULDER STRAP ASSEMBLY, INCLUDES: PLASTIC TAB, STRAP, HARDWARE
00650551044888VEST WAIST STRAP ASSEMBLY, INCLUDES: BUCKLE BLOCK, PLASTIC TAB, STRAP, HARDWARE
00650551044864BALL ENDED TORQUE DRIVER BIT, FOR 1201-7 PRECISION TORQUE DRIVER
00650551044840HEAD BLOCK ATTACH HARDWARE SET: (4) SOCKET HEAD CAP SCREWS, (4) WASHERS, (2) ALLEN WRENCHES
00650551044826COMBINATION WRENCH OPEN END/BOX WRENCH
00650551044819DISPOSABLE TORQUE DRIVER
00650551044598HEAD SPOON
00650551044567TRACTION TONG, LARGE, WITH (2) 2.5" PRESSURE SKULL PINS
00650551044550TRACTION TONG PRESSURE PIN SET OF (2) 3" PINS
00650551044543TRACTION TONG PRESSURE PIN SET OF (2) 2.5" PINS
10650551044496TITANIUM SKULL PIN, INCLUDES LOCKING NUT
006505510443831233-5 HALO VEST, XX-LARGE, LAMBSWOOL LINER
006505510443761233-5 HALO VEST, XX-LARGE, COOLMAX LINER
006505510443691233-5 HALO VEST, XX-LARGE, ACRYLIC LINER
006505510443451233-5 HALO VEST, X-LARGE, COOLMAX LINER
006505510443381233-5 HALO VEST, X-LARGE, ACRYLIC LINER
006505510443211233-5 HALO VEST, SMALL, LAMBSWOOL LINER
006505510443141233-5 HALO VEST, SMALL, COOLMAX LINER
006505510443071233-5 HALO VEST, SMALL, ACRYLIC LINER
006505510442911233-5 HALO VEST, MEDIUM, LAMBSWOOL LINER
006505510442841233-5 HALO VEST, MEDIUM, COOLMAX LINER
006505510442771233-5 HALO VEST, MEDIUM, ACRYLIC LINER
006505510442601233-5 HALO VEST, LARGE, LAMBSWOOL LINER
006505510442531233-5 HALO VEST, LARGE, COOLMAX LINER
006505510442461233-5 HALO VEST, LARGE, ACRYLIC LINER
006505510442391233-5 CUSTOM HALO VEST, LAMBSWOOL LINER
006505510442221233-5 CUSTOM HALO VEST, COOLMAX LINER
006505510442151233-5 CUSTOM HALO VEST, ACRYLIC LINER
00650551044208LAMBSWOOL LINER, FOR 1233-5 HALO VEST, XX-LARGE
00650551044192LAMBSWOOL LINER, FOR 1233-5 HALO VEST, X-LARGE
00650551044185LAMBSWOOL LINER, FOR 1233-5 HALO VEST, SMALL

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