FDA UDI
In Commercial Distribution
🇺🇸 United States
Adante Traction Mount, Left
DI: 00842430117022
·
Model: 6895-1147
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Adante Traction Mount, Left
- Primary DI
- 00842430117022
- Version / Model
- 6895-1147
- Catalog Number
- 6895-1147
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-04
- Public Version
- 1
- Public Version Date
- 2025-07-14
- Public Version Status
- New
- Public Device Record Key
- 68e30c74-767f-4c5c-878c-346bc9af491f
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
- 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 |
|---|---|---|---|---|
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67461 | Operating table/boot traction interface controller | An electrically-powered, orthopaedic device intended to be connected to an operating table orthopaedic extension at one end and hold a traction boot at the other end to: 1) electrically control the fine traction and enable locking/unlocking of the gross traction of the extension, and 2) manually rotate the patient’s foot, as part of a lower limb surgical procedure; the extension and boot are not included. It is an electrical unit with appropriate control handle/buttons, connectors, and a clamp-like device intended to hold the boot. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430117022 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]