FDA UDI
In Commercial Distribution
🇺🇸 United States
Antalgic Trak
DI: 00860000487504
·
Model: AT1000
·
ANTALGIC-TRAK
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Antalgic Trak
- Primary DI
- 00860000487504
- Version / Model
- AT1000
- Company Name
- ANTALGIC-TRAK
- Labeler DUNS
- 043600853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-30
- Public Version
- 1
- Public Version Date
- 2018-11-30
- Public Version Status
- New
- Public Device Record Key
- 6b98fe72-e203-443a-a1aa-f924906f7daf
Device Description
Power Traction Equipment
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
- 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 |
|---|---|---|---|---|
| ITH | Equipment, Traction, Powered | Physical Medicine | 890.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14105 | Static powered traction system | An assembly of devices designed to apply continuous traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of a mains electricity (AC-powered) motor with a control unit to generate and regulate the mechanical forces, and a cord (e.g., braided nylon) clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used to widen intervertebral spaces to treat prolapsed intervertebral disks and other disorders. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00860000487511 | GS1 | Inner pack | 1 | In Commercial Distribution | |
| Primary | 00860000487504 | GS1 |
Customer Contacts
- Phone
- 8007923575
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042482 | 000 |