NA
- Primary DI
- 04042409200076
- Brand
- NA
- Company
- aap Implantate AG
- Model
- SC 4050-10-2
- Catalog number
- SC 4050-10-2
- Device description
- Cannulated screw 4.0, long thread 5, L 10
- Published
- 2016-08-18
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HWC | Screw, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K111316 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04042409200076 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04042409200076 | 04042409200076 | 4042409200076 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone screw (non-sliding) | A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 328420633
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04042409200021 | NA | SC 4030-46-2 | SC 4030-46-2 | 2016-08-18 |
| 04042409200038 | NA | SC 4030-48-2 | SC 4030-48-2 | 2016-08-18 |
| 04042409200045 | NA | SC 4030-50-2 | SC 4030-50-2 | 2016-08-18 |
| 04042409200083 | NA | SC 4050-12-2 | SC 4050-12-2 | 2016-08-18 |
| 04042409200090 | NA | SC 4050-14-2 | SC 4050-14-2 | 2016-08-18 |
| 04042409200106 | NA | SC 4050-16-2 | SC 4050-16-2 | 2016-08-18 |
| 04042409200120 | NA | SC 4050-18-2 | SC 4050-18-2 | 2016-08-18 |
| 04042409200151 | NA | SC 4050-20-2 | SC 4050-20-2 | 2016-08-18 |
| 04042409200168 | NA | SC 4050-22-2 | SC 4050-22-2 | 2016-08-18 |
| 04042409236990 | NA | SC 4030-46 | SC 4030-46 | 2016-08-18 |
| 04042409237003 | NA | SC 4030-48 | SC 4030-48 | 2016-08-18 |
| 04042409237010 | NA | SC 4030-50 | SC 4030-50 | 2016-08-18 |
| 04042409237027 | NA | SC 4030-55 | SC 4030-55 | 2016-08-18 |
| 04042409035807 | NA | IP 0104-00 | 2018-02-28 | |
| 04042409035845 | NA | IP 0104-01 | 2018-02-28 | |
| 04042409002939 | NA | IP 8403-00 | 2018-02-28 | |
| 04042409036170 | NA | IP 2505-00 | 2018-02-28 | |
| 04042409207273 | NA | IP 8405-00 | 2018-02-28 | |
| 04042409228995 | NA | IP 8405-50 | 2018-02-28 | |
| 04042409363337 | NA | IP 2506-00 | 2018-02-28 |
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