FDA UDI
In Commercial Distribution
🇺🇸 United States
Cervico2000
DI: 07290015711203
·
Model: CERV8
·
MEDITRAC LTD.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Cervico2000
- Primary DI
- 07290015711203
- Version / Model
- CERV8
- 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
- 3e86f272-4542-4a74-bc13-0ad8e840fcc1
Device Description
The Cervico 2000 provides safe, simple, compact, and effective treatment of cervical 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. The Cervico 2000 allows the patient maximum mobility with minimal restrictions or discomfort during treatment. The Cervico 2000 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 |
|---|---|---|---|---|
| HST | Apparatus, Traction, Non-Powered | Orthopedic | 888.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61203 | Wearable cervical spine traction device | An externally-worn orthopaedic device intended to apply traction to the cervical spine/neck to treat pain resulting from non-bone injuries/disorders (e.g., discogenic, occupational, sports, whiplash). It may include moulded components that fit superiorly under the chin and base of the skull, and inferiorly over the base of the neck and collar bone, with rods holding the components apart that can be adjusted to apply traction forces by separation. 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 | 07290015711203 | GS1 | ||||
| Package | 17290015711200 | GS1 | Carton | 1 | In Commercial Distribution | |
| Package | 37290015711204 | GS1 | Carton | 3 | In Commercial Distribution | |
| Package | 67290015711205 | GS1 | Carton | 6 | In Commercial Distribution |