FDA UDI
In Commercial Distribution
🇺🇸 United States
CAT Pro Select
DI: G041CT0120
·
Model: CT012
·
JTECH Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CAT Pro Select
- Primary DI
- G041CT0120
- Version / Model
- CT012
- Company Name
- JTECH Medical
- Labeler DUNS
- 625089131
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-14
- Public Version
- 2
- Public Version Date
- 2023-07-13
- Public Version Status
- Update
- Public Device Record Key
- 3dda097c-2242-4a83-a579-999a5f1ff74a
Device Description
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| LXM | Manipulator, Plunger-Like Joint | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63426 | Joint/spinal manipulator, mechanical | A hand-held, non-electric, mechanically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The instrument uses a manually-operated, mechanical, plunger-like mechanism (e.g., spring-loaded) to deliver thrust to the patient's body via its rounded distal end (e.g., rubber-tipped stylus); it typically has two or more force settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G041CT0120 | HIBCC |
Customer Contacts
- Phone
- 385-695-5000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974376 | 000 |