FDA UDI
In Commercial Distribution
🇺🇸 United States
CHATTANOOGA
DI: 00888912368247
·
Model: 6874-2-X
·
DJO, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CHATTANOOGA
- Primary DI
- 00888912368247
- Version / Model
- 6874-2-X
- Company Name
- DJO, LLC
- Labeler DUNS
- 081840873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8135a4f2-9807-480e-ae4f-8e7f9df494b3
Device Description
TX ADP400 TRACTION ACCESSORY PACKAGE - BLACK
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ITH | EQUIPMENT, TRACTION, POWERED | Physical Medicine | 890.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45538 | Static/intermittent powered traction system, mobile | An assembly of devices designed to apply continuous and/or various intermittent (regular, progressive/regressive, cycled) traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It is designed to be placed on a trolley (cart) that can be rolled to a table or chair to apply horizontal or vertical traction. It usually consists of an AC-powered motor with a control unit used to generate and regulate the mechanical forces, and a cord 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. It is used primarily to widen intervertebral spaces. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888912368247 | GS1 |