FDA UDI
In Commercial Distribution
🇺🇸 United States
TRITON (SZER. 70)
DI: 05903684802142
·
Model: 6 E
·
MEDEN INMED SP Z O O
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TRITON (SZER. 70)
- Primary DI
- 05903684802142
- Version / Model
- 6 E
- Catalog Number
- 4769E
- Company Name
- MEDEN INMED SP Z O O
- Labeler DUNS
- 367142903
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 1
- Public Version Date
- 2022-11-15
- Public Version Status
- New
- Public Device Record Key
- 4d6589f3-8980-41cd-9532-39e514be5841
Device Description
TRITON DTS® 6E is designed to support a patient and the therapist in traction treatment. The table surface may consist of sections that can be raised and lowered to manipulate the curvature of the patient’s spine and traction accessories for lumbar and cervical traction.
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
- Yes
- 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 |
|---|---|---|---|---|
| INQ | Table, Powered | Physical Medicine | 890.3760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46761 | Body arch traction table | A fixed framework table designed to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch. The patient locks their feet behind a cross-member and bends backward over the curvature of the table to flex the vertebrae of the spine, relieving spinal compression, relaxing the shoulders, neck, and back muscles, whilst stretching and strengthening the core muscles of the body. This device can be used in a healthcare facility or in the home to assist patients eliminate/alleviate back pain. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05903684802142 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 295 | Centimeter | |
| Height | 95 | Centimeter | |
| Width | 70 | Centimeter |