FDA UDI
In Commercial Distribution
🇺🇸 United States
UroWire® Guidewire with SL-6® Hydrophilic Coating
DI: 00607915113858
·
Model: B8634
·
APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- UroWire® Guidewire with SL-6® Hydrophilic Coating
- Primary DI
- 00607915113858
- Version / Model
- B8634
- Company Name
- APPLIED MEDICAL RESOURCES CORPORATION
- Labeler DUNS
- 187129135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-18
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e76a4bb0-6e4b-49cd-aec5-af408e188d28
Device Description
Urological Guidewire
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
- Yes
- 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 |
|---|---|---|---|---|
| KNY | Accessories, Catheter, G-U | Gastroenterology, Urology | 876.5130 | 2 |
| EZB | Stylet For Catheter, Gastro-Urology | Gastroenterology, Urology | 876.5130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45623 | General-purpose non-vascular guidewire | A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10607915113855 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00607915113858 | GS1 |
Customer Contacts
- Phone
- 1.949.713.8300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Centimeter | |
| Outer Diameter | 0.35 | Inch |