PMT® CORPORATION HALO 1203-5SL

GUDID 00650551043195

1203-5 HALO VEST, SMALL, LAMBSWOOL LINER

PMT CORPORATION

Cervical spine immobilization system, single-use

• Primary Device ID: 00650551043195
• NIH Device Record Key: 98f81745-2988-4b08-9beb-4c8db4740510
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMT® CORPORATION HALO
• Version Model Number: 1203-5SL
• Catalog Number: 1203-5SL
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551043195 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-15

On-Brand Devices [PMT® CORPORATION HALO]

• 00650551045830: TRACTION BAIL WITH HEADBLOCK ATTACHMENT HARDWARE
• 00650551045144: TITANIUM "S" HOOK
• 00650551045120: TRACTION TONG, MEDIUM, WITH (2) 3" PRESSURE PINS
• 00650551045113: TRACTION TONG, SMALL, WITH (2) 2.5" PRESSURE PINS
• 00650551045106: 1208-1 OPEN BACK HALO RING, X-LARGE, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PIN
• 00650551045090: 1208-1 OPEN BACK HALO RING, SMALL, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PINS
• 00650551045083: 1208-1 OPEN BACK HALO RING, MEDIUM, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PINS
• 00650551045076: 1208-1 OPEN BACK HALO RING, LARGE, INCLUDES (4) 3" PRESSURE SKULL PINS AND (3) POSITIONING PINS
• 00650551045007: TRACTION BAIL
• 00650551044994: POSTERIOR BED ADAPTER, FOR MAYFIELD RADIOLUCENT
• 00650551044987: ANTERIOR BED ADAPTER, FOR MAYFIELD RADIOLUCENT
• 00650551044970: SURGICAL BED ADAPTER, ANTERIOR & POSTERIOR
• 00650551044963: SURGICAL BED ADAPTER, POSTERIOR
• 00650551044956: SURGICAL BED ADAPTER, ANTERIOR
• 00650551044949: TORQUE DRIVER
• 00650551044932: PRECISION TORQUE DRIVER
• 00650551044925: HEADHOLDER, FOR ATTACHING OPEN BACK RINGS
• 00650551044918: DOUBLE ENDED TORQUE DRIVER BIT, FOR 1201-8 TORQUE WRENCH
• 00650551044901: WRENCH SET: 2 ALLEN WRENCHS & 1 COMBO WRENCH
• 00650551044895: SHOULDER STRAP ASSEMBLY, INCLUDES: PLASTIC TAB, STRAP, HARDWARE
• 00650551044888: VEST WAIST STRAP ASSEMBLY, INCLUDES: BUCKLE BLOCK, PLASTIC TAB, STRAP, HARDWARE
• 00650551044864: BALL ENDED TORQUE DRIVER BIT, FOR 1201-7 PRECISION TORQUE DRIVER
• 00650551044840: HEAD BLOCK ATTACH HARDWARE SET: (4) SOCKET HEAD CAP SCREWS, (4) WASHERS, (2) ALLEN WRENCHES
• 00650551044826: COMBINATION WRENCH OPEN END/BOX WRENCH
• 00650551044819: DISPOSABLE TORQUE DRIVER
• 00650551044598: HEAD SPOON
• 00650551044567: TRACTION TONG, LARGE, WITH (2) 2.5" PRESSURE SKULL PINS
• 00650551044550: TRACTION TONG PRESSURE PIN SET OF (2) 3" PINS
• 00650551044543: TRACTION TONG PRESSURE PIN SET OF (2) 2.5" PINS
• 10650551044496: TITANIUM SKULL PIN, INCLUDES LOCKING NUT
• 00650551044383: 1233-5 HALO VEST, XX-LARGE, LAMBSWOOL LINER
• 00650551044376: 1233-5 HALO VEST, XX-LARGE, COOLMAX LINER
• 00650551044369: 1233-5 HALO VEST, XX-LARGE, ACRYLIC LINER
• 00650551044345: 1233-5 HALO VEST, X-LARGE, COOLMAX LINER
• 00650551044338: 1233-5 HALO VEST, X-LARGE, ACRYLIC LINER
• 00650551044321: 1233-5 HALO VEST, SMALL, LAMBSWOOL LINER
• 00650551044314: 1233-5 HALO VEST, SMALL, COOLMAX LINER
• 00650551044307: 1233-5 HALO VEST, SMALL, ACRYLIC LINER
• 00650551044291: 1233-5 HALO VEST, MEDIUM, LAMBSWOOL LINER
• 00650551044284: 1233-5 HALO VEST, MEDIUM, COOLMAX LINER
• 00650551044277: 1233-5 HALO VEST, MEDIUM, ACRYLIC LINER
• 00650551044260: 1233-5 HALO VEST, LARGE, LAMBSWOOL LINER
• 00650551044253: 1233-5 HALO VEST, LARGE, COOLMAX LINER
• 00650551044246: 1233-5 HALO VEST, LARGE, ACRYLIC LINER
• 00650551044239: 1233-5 CUSTOM HALO VEST, LAMBSWOOL LINER
• 00650551044222: 1233-5 CUSTOM HALO VEST, COOLMAX LINER
• 00650551044215: 1233-5 CUSTOM HALO VEST, ACRYLIC LINER
• 00650551044208: LAMBSWOOL LINER, FOR 1233-5 HALO VEST, XX-LARGE
• 00650551044192: LAMBSWOOL LINER, FOR 1233-5 HALO VEST, X-LARGE
• 00650551044185: LAMBSWOOL LINER, FOR 1233-5 HALO VEST, SMALL