FDA UDI
In Commercial Distribution
🇺🇸 United States
NEOFIX
DI: 07899893205165
·
Model: 901.502
·
Neoortho Produtos Ortopédicos S/A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NEOFIX
- Primary DI
- 07899893205165
- Version / Model
- 901.502
- Company Name
- Neoortho Produtos Ortopédicos S/A.
- Labeler DUNS
- 914644351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 72664b6a-911b-4ec3-be45-6b2d42bcc85f
Device Description
Star Head Insertion Locking Screw NEOFIX D2.4
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
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47749 | Orthopaedic fixation plate bending insert, single-use | A non-sterile device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head used solely during the bending of plates that typically have a continuous row of screw holes. This is a single-use device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899893205165 | GS1 |
Customer Contacts
- Phone
- +554135351000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142419 | 000 |