FDA UDI
In Commercial Distribution
🇺🇸 United States
Vertetrac
DI: 07290015711104
·
Model: VERT9
·
MEDITRAC LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vertetrac
- Primary DI
- 07290015711104
- Version / Model
- VERT9
- Company Name
- MEDITRAC LTD.
- Labeler DUNS
- 514587369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-25
- Public Version
- 1
- Public Version Date
- 2022-08-02
- Public Version Status
- New
- Public Device Record Key
- 9fbd4a3a-447e-413b-968a-3c4e4124d970
Device Description
The Vertetrac provides safe, simple, compact, and effective treatment of lumbar spine disorders and brings to both the patient and physician a means of powerful, dynamic traction with simultaneous, three-dimensional action without the need for traction beds or restrictive braces. Thus, the Vertetrac allows the patient maximum mobility with minimal restrictions or discomfort during treatment. The Vertetrac facilitates the treatment of the patient by the health service professional while also allowing chronic sufferers to administer self-treatment under qualified medical supervision.
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IQE | Orthosis, Lumbar | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61214 | Wearable lumbar spine traction device | An externally-worn orthopaedic device designed to apply traction to the lumbar spine to relieve symptoms of back pain and sciatica. It consists of adjustable components worn superiorly under the rib cage, and inferiorly over the iliac crests, with rods holding the components apart that can be adjusted to apply traction forces by separation. It may include an additional attachable component intended for the treatment of scoliosis. It is intended for use in the home or a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290015711104 | GS1 | ||||
| Package | 17290015711101 | GS1 | Carton | 1 | In Commercial Distribution | |
| Package | 37290015711105 | GS1 | Carton | 3 | In Commercial Distribution |