FDA UDI
In Commercial Distribution
🇺🇸 United States
iTrac
DI: 00852753008945
·
Model: T9000
·
PIVOTAL HEALTH SOLUTIONS, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iTrac
- Primary DI
- 00852753008945
- Version / Model
- T9000
- Company Name
- PIVOTAL HEALTH SOLUTIONS, INC.
- Labeler DUNS
- 826316098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-16
- Public Version
- 1
- Public Version Date
- 2018-11-16
- Public Version Status
- New
- Public Device Record Key
- 86e8e99b-6f4a-40cf-a564-56802d9697d4
Device Description
itrac 115V
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILZ | Accessories, Traction | Physical Medicine | 890.5925 | 1 |
| IRS | Head Halter, Traction | Physical Medicine | 890.5925 | 1 |
| ITH | Equipment, Traction, Powered | Physical Medicine | 890.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46083 | Traction table, line-powered | A mobile, mains electricity (AC-powered) table designed to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient?s spine, or apply a rotational roller mechanism protruding through the table surface to the spine, or employ masts and traction accessories for lumbar and cervical traction in a sitting position. Interchangeable traction devices such as head halters, pelvic belts, traction boots, and a traction unit may be used with this table. It is used in a healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852753008945 | GS1 |