Halo Systems 516V2S
GUDID 05690977368934
Skull Pin 3in TI Sterl 1PK
OSSUR AMERICAS, INC.
Cervical spine immobilization head ring pin| Primary Device ID | 05690977368934 |
| NIH Device Record Key | 8f790cbe-3c3f-4c16-bb59-ccf61ed8494d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Halo Systems |
| Version Model Number | 516V2S |
| Catalog Number | 516V2S |
| 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 | 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 | 05690977368934 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K822780
FDA Product Code
| JEC | COMPONENT, TRACTION, INVASIVE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
Ethylene Oxide
[05690977368934]
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 |
Trademark Results [Halo Systems]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HALO SYSTEMS 97135976 not registered Live/Pending |
Bruce Hirschorn 2021-11-21 |
 HALO SYSTEMS 86086367 not registered Dead/Abandoned |
Halo Audio, LLC 2013-10-08 |
 HALO SYSTEMS 86086365 not registered Dead/Abandoned |
Halo Audio, LLC 2013-10-08 |
 HALO SYSTEMS 85104884 3947314 Live/Registered |
HIRSCHORN, BRUCE, MR. 2010-08-11 |
 HALO SYSTEMS 77840278 3806151 Live/Registered |
HIRSCHORN, BRUCE, MR. 2009-10-02 |
 HALO SYSTEMS 77605021 not registered Dead/Abandoned |
The Technical Advantage, Inc. 2008-10-31 |
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