FDA UDI
In Commercial Distribution
🇺🇸 United States
ART End Cap
DI: B058ART13C051
·
Model: ART13C05
·
Orthopedic Designs North America, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ART End Cap
- Primary DI
- B058ART13C051
- Version / Model
- ART13C05
- Catalog Number
- ART-13-C05
- Company Name
- Orthopedic Designs North America, Inc.
- Labeler DUNS
- 945518848
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-29
- Public Version
- 1
- Public Version Date
- 2021-12-07
- Public Version Status
- New
- Public Device Record Key
- 00b8ef7d-530b-439e-a73c-d86bff8ee618
Device Description
ART End Cap Ø13mm x 05mm (+05)
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
- Yes
- 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 end-cap | A small, 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. 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 | B058ART13C051 | HIBCC |
Customer Contacts
- Phone
- 888-635-8535
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152295 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 13 | Millimeter | |
| Length | 05 | Millimeter |