FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RFS™ Screw
DI: E302RFSC40409
·
Model: RFS-C4040
·
Bioretec Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RFS™ Screw
- Primary DI
- E302RFSC40409
- Version / Model
- RFS-C4040
- Catalog Number
- RFS-C4040
- Company Name
- Bioretec Oy
- Labeler DUNS
- 368715301
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-23
- Public Version
- 5
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 9a36e1c1-46ed-4718-b0df-f8db160cab00
- Distribution End Date
- 2017-12-31
Device Description
RFS™ Screw Cannulated 4.0 x 40 mm
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
- MR Safe
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45039 | Bioabsorbable orthopaedic bone screw | A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E302RFSC40409 | HIBCC |
Customer Contacts
- Phone
- +358207789500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081392 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 4.0 | Millimeter | |
| Length | 40 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius