FDA UDI
In Commercial Distribution
🇺🇸 United States
PURIST - Leg positioning system
DI: 03701602300105
·
Model: 6813100
·
Innovative Orthopedic Technologies AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PURIST - Leg positioning system
- Primary DI
- 03701602300105
- Version / Model
- 6813100
- Catalog Number
- 6813100
- Company Name
- Innovative Orthopedic Technologies AG
- Labeler DUNS
- 480626052
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-13
- Public Version
- 2
- Public Version Date
- 2026-04-15
- Public Version Status
- Update
- Public Device Record Key
- 88c66372-1551-4c54-a57d-91bf00797eca
Device Description
The device is intended to position the foot of the leg during a knee joint operation.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| BWN | Table And Attachments, Operating-Room | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42308 | Operating table orthopaedic extension, non-powered | A non-powered, orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder or spinal surgery, C- or O-arm use). It typically consists of height, length and angle adjustable supports or telescopic bars/plates (e.g., leg spar). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701602300105 | GS1 |
Customer Contacts
- Phone
- +1 409 658 1017
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry