PMT CORPORATION HALO

GUDID 00650551146964

HEADBLOCK PARTS REPLACEMENT KIT: (4) 1 3/4" SHCS, (8) WASHERS, (4) LOCK WASHERS, (8) SET SCREWS, (2) BOLT STRAPS, (2)ALLEN WRENCH FOR OPEN BACK RINGS

PMT CORPORATION

Cervical spine immobilization system, single-use

• Primary Device ID: 00650551146964
• NIH Device Record Key: 2df410d9-4e31-47c9-82cf-3c5ebf5e93b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMT CORPORATION HALO
• Version Model Number: 1201-35
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551146964 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-20
• Device Publish Date: 2021-07-12

On-Brand Devices [PMT CORPORATION HALO]

• 00650551143734: TRACTION BAIL, FOR DIRECT ATTACHMENT TO A HALO RING
• 00650551142874: LOCKING HALO ROD CLAMPS, SET OF 8
• 00650551142591: 1211-1 OPEN BACK HALO RING, X-SMALL, (10) 2 1/2" PINS AND (3) POSITIONING PINS
• 00650551142508: 1211-1 OPEN BACK HALO RING, XX-LARGE, INCLUDES (5) 3" SKULL PINS AND (3) POSITIONING PINS
• 00650551141686: TRACTION BAIL HARDWARE - (2) 3/4" SHCS, (2) WASHERS, (1) ALLEN WRENCH
• 00650551144014: TRACTION BAIL, SHORT
• 00650551146964: HEADBLOCK PARTS REPLACEMENT KIT: (4) 1 3/4" SHCS, (8) WASHERS, (4) LOCK WASHERS, (8) SET SCREWS,
• 00650551146933: OPEN BACK RING – LARGE, (5)3" SKULL PINS, (3)POSITIONING PINS, 21 PIN SITES
• 00650551146926: OPEN BACK RING – MEDIUM, (5)3" SKULL PINS, (3)POSITIONING PINS, 21 PIN SITES
• 00650551146919: OPEN BACK RING – SMALL, (5)3" SKULL PINS, (3)POSITIONING PINS, 21 PIN SITES
• 00650551146407: BLACK KNOB FOR SURGICAL BED ADAPTER
• 00650551148982: CUSTOM VEST
• 00650551148609: 1223-5 CUSTOM HALO VEST WITH AIRBAG, LAMBSWOOL LINER, REQUIRES SIZING MEASUREMENT TO ORDER