FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Flex-Ez Guidewire
DI: M84934060
·
Model: 3406
·
HOBBS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Flex-Ez Guidewire
- Primary DI
- M84934060
- Version / Model
- 3406
- Catalog Number
- 3406
- Company Name
- HOBBS MEDICAL, INC.
- Labeler DUNS
- 076769355
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2025-12-22
- Public Version Status
- Update
- Public Device Record Key
- 4b631ea1-b11a-43dd-9378-aebd997b2144
- Distribution End Date
- 2025-12-05
Device Description
A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device
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
- 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 |
|---|---|---|---|---|
| EYB | Catheter, Ureteral, Gastro-Urology | Gastroenterology, Urology | 876.5130 | 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 |
|---|---|---|---|---|---|---|
| Primary | M84934060 | HIBCC |
Customer Contacts
- Phone
- 8606845875
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K914358 | 000 |