FDA UDI
In Commercial Distribution
🇺🇸 United States
The Tether™
DI: 03662663080842
·
Model: 240H6004
·
Highridge Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- The Tether™
- Primary DI
- 03662663080842
- Version / Model
- 240H6004
- Catalog Number
- 240H6004
- Company Name
- Highridge Medical, LLC
- Labeler DUNS
- 119260394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-06
- Public Version
- 1
- Public Version Date
- 2025-02-14
- Public Version Status
- New
- Public Device Record Key
- 80744235-b2e7-4528-8f28-c704243a7293
Device Description
Tether Tension Indicator
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QHP | Vertebral body tethering system | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65554 | Anterior spinal tethering system tether | An implantable, flexible band or cord that is a component of an anterior spinal tethering system and intended to provide restrictive force on one side of the spine to allow growth on the contralateral side, to help achieve straightening of the spine in the treatment of idiopathic scoliosis. It is designed as a longitudinal (intervertebral) component intended to be attached to adjacent vertebral body screws/anchors (not included). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03662663080842 | GS1 |
Customer Contacts
- Phone
- +1(800)447-3625
- [email protected]