FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Halo Systems
DI: 05690977196636
·
Model: 538
·
OSSUR AMERICAS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Halo Systems
- Primary DI
- 05690977196636
- Version / Model
- 538
- Catalog Number
- 538
- 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
- 12c98efc-878b-4d00-ad74-f6c837318ea8
- Distribution End Date
- 2020-02-28
Device Description
HALO APPLICATION TRAY
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 |
|---|---|---|---|---|
| KDD | Kit, surgical instrument, disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46537 | Cervical spine immobilization head ring | A loop (halo) that is part of a cervical spine immobilization system (commonly known as a Halo vest) and designed to be fixed to the skull of a patient at brow level using pointed, steel, threaded bolts (typically four) that are adjusted to penetrate the outer bone of the skull. Vertical, adjustable rods from the Halo vest are locked to this loop, and a traction upon the cervical spine is created, holding the head firmly in place relative to the torso so that cervical vertebrae are immobilized following surgery or injury. It may be made of ferrous or non-ferromagnetic materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05690977196636 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K864969 | 000 |