FDA UDI
In Commercial Distribution
🇺🇸 United States
SMARTNAIL
DI: 10845854014929
·
Model: 532445
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SMARTNAIL
- Primary DI
- 10845854014929
- Version / Model
- 532445
- Catalog Number
- 532445
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 0f910cec-42a2-4aae-884c-8662a0e9f554
Device Description
SMARTNAIL 2.4X45 96/4 PLA
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
- No
- 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 |
|---|---|---|---|---|
| MAI | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45037 | Orthopaedic bone pin, bioabsorbable | A device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10845854014929 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.4 | Millimeter | |
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP DRY
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- – 104 Degrees Fahrenheit