FDA UDI
In Commercial Distribution
🇺🇸 United States
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
DI: 07540194004239
·
Model: SLM-CAP-415
·
Orthopediatrics Canada ULC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
- Primary DI
- 07540194004239
- Version / Model
- SLM-CAP-415
- Catalog Number
- SLM-CAP-415
- Company Name
- Orthopediatrics Canada ULC
- Labeler DUNS
- 243298854
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 9
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- b527ecfb-9469-49cb-b343-71f6eccd3b08
Device Description
SLIM Rod Cap Small M4.5 x 1.5mm
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46139 | Bone nail implantable cap | A small, implantable, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. Commonly known as an end-cap, it is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540194004239 | GS1 |
Customer Contacts
- Phone
- +1(450)688-5144 ext. 242
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143355 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1.5 | Millimeter | |
| Outer Diameter | 4.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep at room temperature