FDA UDI
In Commercial Distribution
🇺🇸 United States
CONMED
DI: 10845854034071
·
Model: C8006
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
5
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Basic Information
- Brand Name
- CONMED
- Primary DI
- 10845854034071
- Version / Model
- C8006
- Catalog Number
- C8006
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2023-12-05
- Public Version
- 4
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 72832be6-9196-4d46-8936-b4f661fd5613
Device Description
NITINOL GUIDEWIRE, 0.8 MM (.032") X 356 MM (14")
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46165 | Orthopaedic guidewire, reusable | A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00845854034074 | GS1 | ||||
| Direct Marking | 20845854034078 | GS1 | ||||
| Primary | 10845854034071 | GS1 | ||||
| Previous | 30845854034075 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.8 | Millimeter |