FDA UDI
In Commercial Distribution
🇺🇸 United States
PolyLock Midfoot
DI: 00840124502451
·
Model: TN-LL-7000-15L
·
FUSION ORTHOPEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PolyLock Midfoot
- Primary DI
- 00840124502451
- Version / Model
- TN-LL-7000-15L
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-07
- Public Version
- 2
- Public Version Date
- 2025-07-18
- Public Version Status
- Update
- Public Device Record Key
- 1433c00e-727b-4ebf-90ba-f4efa2fea26e
Device Description
(not in use)
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40591 | Leg friction/impact protector | A device designed to be worn over the leg to provide a cushion to protect the limb and its skin from friction against surfaces and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the leg, or has a tubular sock design; it is not dedicated to the ankle/foot. It is typically used by persons who have thinning skin or skin sores on their legs, are bedridden, or prone to lack of control with their legs causing injury. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840124502451 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211843 | 000 |