FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Halo Systems
DI: 05690977197299
·
Model: JT-110
·
OSSUR AMERICAS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Halo Systems
- Primary DI
- 05690977197299
- Version / Model
- JT-110
- Catalog Number
- JT-110
- Company Name
- OSSUR AMERICAS, INC.
- Labeler DUNS
- 139280028
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-16
- Public Version
- 3
- Public Version Date
- 2020-07-22
- Public Version Status
- Update
- Public Device Record Key
- a62d85fe-1e2d-4ea7-ad9c-65e2aebd04f8
- Distribution End Date
- 2020-02-28
Device Description
J TONG ONLY MED/LGE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAX | TONG, SKULL FOR TRACTION | Neurology | 882.5960 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46528 | Traction system skull tongs | A device designed to provide traction to the cervical spine by applying an upward longitudinal force from a traction system to the skull that causes hyperextension of the head and neck. It is typically a two-arm pivoted device that is attached to the skull using pins (partially implanted or not); the proximal end includes a mechanism (e.g., an adjustable threaded bolt and nut) responsible for the application of the traction force. It typically includes straps for connection to the traction system and is used in the management/treatment of damage to the cervical spine, aligns vertebral structures and provides stabilization for a cervical spine injury caused by trauma or disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05690977197299 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930021 | 000 |