FDA UDI
In Commercial Distribution
🇺🇸 United States
K-FIX®
DI: 10381780357490
·
Model: 119050ND
·
NEWDEAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- K-FIX®
- Primary DI
- 10381780357490
- Version / Model
- 119050ND
- Company Name
- NEWDEAL
- Labeler DUNS
- 536935331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-11-23
- Public Version
- 3
- Public Version Date
- 2023-02-08
- Public Version Status
- Update
- Public Device Record Key
- a8da6ddf-7fac-486f-b2b6-b6cfe006bc9d
- Distribution End Date
- 2026-10-26
Device Description
The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three main functions in foot surgery for protruding wires. It protects patients and/or hospital staff from wire sharp ends. It prevents any inward pin migration as well as reducing bandage size. It allows easy removal of the wire by the surgeon. Its fixation requires no instrument. The protector ball is introduced until firm locking on the wire extremity previously bent.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46505 | Surgical instrument guard, single-use, sterile | A sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00381780357493 | GS1 | ||||
| Primary | 10381780357490 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022597 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry place