Halo Systems 505400V2

GUDID 05690977305922

OPEN BACK GLASS HALO STD

OSSUR AMERICAS, INC.

Cervical spine immobilization system, single-use

• Primary Device ID: 05690977305922
• NIH Device Record Key: 0396240c-12c9-4a5c-b068-2576801b0d5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halo Systems
• Version Model Number: 505400V2
• Catalog Number: 505400V2
• Company DUNS: 139280028
• Company Name: OSSUR AMERICAS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	05690977305922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051918

FDA Product Code

• HAX: TONG, SKULL FOR TRACTION

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

[05690977305922]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-16

On-Brand Devices [Halo Systems]

• 05690977370524: RESOLVE TRACTION HOOP ASSM
• 05690977368972: RESOLVE POSITION PINS & PADS
• 05690977368965: Skull Pin 2-1/4in CT Sterl 6PK
• 05690977368958: Skull Pin 3in TI Sterl 5 PK
• 05690977368941: Skull Pin 2-1/4in TI Sterl 5PK
• 05690977368934: Skull Pin 3in TI Sterl 1PK
• 05690977343306: CB RING TRAY LG
• 05690977343283: CB RING TRAY STD
• 05690977343269: CB RING TRAY SM
• 05690977334960: CB RING KIT TI SM-No App
• 05690977326200: CB RING KIT TI LG-No App
• 05690977319035: CB RING KIT TI STD-No App
• 05690977309357: Kit Closed Back Halo Lg
• 05690977309340: Kit Closed Back Halo Sm
• 05690977309333: Kit Closed Back Halo Md
• 05690977308718: J TONG SML/MED- No App
• 05690977308701: J TONG MED/LGE-No App
• 05690977308695: OB V2 RING KIT TI LG-No App
• 05690977308688: OB V2 RING KIT TI STD-No App
• 05690977308671: OB V2 RING KIT TI SM-No App
• 05690977308664: OB RESOLVE RING KIT LG-No App
• 05690977308657: OB RESOLVE RING KIT STD-No App
• 05690977308640: OB RESOLVE RING KIT SM-No App
• 05690977308633: CB RESOLVE RING KIT LG-No App
• 05690977308626: CB RESOLVE RING KIT STD-No App
• 05690977308596: CB RESOLVE RING KIT SM-No App
• 05690977307599: PRESET TORQUE SCREWDRIVER 8LB
• 05690977305922: OPEN BACK GLASS HALO STD
• 05690977305915: OPEN BACK GLASS HALO SM
• 05690977305908: CB RING KIT TI LG
• 05690977305892: CB RING KIT TI STD
• 05690977305885: CB RING KIT TI SM
• 05690977223370: OB V2 RING KIT TI LG
• 05690977197404: OB RESOLVE COMPONENT TRAY
• 05690977197336: OB RESOLVE STERILE UNIT LGE
• 05690977197329: OB RESOLVE STERILE UNIT STD
• 05690977197312: OB RESOLVE STERILE UNIT SML
• 05690977197305: J TONG ONLY SML/MED
• 05690977197299: J TONG ONLY MED/LGE
• 05690977197282: J TONG ASSEMBLY SML/MED
• 05690977197275: J TONG ASSEMBLY MED/LGE
• 05690977196636: HALO APPLICATION TRAY
• 05690977194090: Skull Pin 2-1/4in CT Sterl 1PK
• 05690977193192: RESOLVE TRACTION HOOP
• 05690977193123: J TONG COMPONENT TRAY
• 05690977192577: Skull Pin 3in CT Sterl 4 PK
• 05690977192348: STERILE V2 COMPONENT TRAY
• 05690977165335: RESOLVE HALO COMP TRAY
• 05690977164130: HALO RINGS LG
• 05690977164116: HALO RINGS MDIUM