FDA UDI
In Commercial Distribution
🇺🇸 United States
SpiraTrax(TM) Sterile Hydro-Slide Guidewire
DI: 06932503510141
·
Model: MTN-BM-89/26-A-W-1
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SpiraTrax(TM) Sterile Hydro-Slide Guidewire
- Primary DI
- 06932503510141
- Version / Model
- MTN-BM-89/26-A-W-1
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-01
- Public Version
- 4
- Public Version Date
- 2025-12-02
- Public Version Status
- Update
- Public Device Record Key
- ef86954f-6817-4940-9caf-5463fdb16827
Device Description
The maximum diameter is 0.035inch,working length is 2600mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface, 0.018inch tip tube
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46691 | Gastro-urological guidewire, single-use | A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16932503510148 | GS1 | BOX | 2 | In Commercial Distribution | |
| Primary | 06932503510141 | GS1 | ||||
| Package | 26932503510145 | GS1 | CASE | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- 877-552-4027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Guidewire Diameter | 0.035 | Inch | |
| Guidewire Length | 2600 | Centimeter |