FDA UDI
In Commercial Distribution
🇺🇸 United States
FOREFOOT SOLUTIONS™
DI: 10381780051862
·
Model: 119105ND
·
NEWDEAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FOREFOOT SOLUTIONS™
- Primary DI
- 10381780051862
- Version / Model
- 119105ND
- Company Name
- NEWDEAL
- Labeler DUNS
- 536935331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-31
- Public Version
- 6
- Public Version Date
- 2023-02-06
- Public Version Status
- Update
- Public Device Record Key
- 192d8677-939e-42c1-b142-2ab54cc59c0b
- Distribution End Date
- 2027-07-11
Device Description
The Scarf clamp is used in Scarf osteotomy, where its specific design (asymmetrical jaws) allows variable lateral displacement and bone fragments holding in the correct position prior to screw fixation.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HXD | CLAMP | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46751 | Bone holding forceps | A manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M248119105ND1 | HIBCC | ||||
| Primary | 10381780051862 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]