FDA UDI
In Commercial Distribution
🇺🇸 United States
Hobbs Pusher Catheter
DI: M84961360
·
Model: 6136
·
HOBBS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hobbs Pusher Catheter
- Primary DI
- M84961360
- Version / Model
- 6136
- Catalog Number
- 6136
- Company Name
- HOBBS MEDICAL, INC.
- Labeler DUNS
- 076769355
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 462caf69-bbc4-4988-b009-e6ac11659ab6
Device Description
A sterile device inserted through a compatible flexible endoscope to aid in implanting a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is commonly made of polytetrafluoroethylene (PTFE). 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 |
|---|---|---|---|---|
| FGE | Catheter, Biliary, Diagnostic | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46689 | Endoscopic stent-placement system | An assembly of sterile devices inserted through a compatible flexible endoscope to implant a stent, typically into a pancreatic or biliary duct in order to maintain patency. It typically consists of a positioning catheter onto which the stent is loaded, a guiding device (commonly known as an introducer or guidewire) that aids the initial placement of the stent, and a pusher catheter that holds the stent in place during withdrawal of the other component devices. It is commonly made of polytetrafluoroethylene (PTFE) [Teflon], or polyethylene (PE). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M84961360 | HIBCC |
Customer Contacts
- Phone
- 8606845875
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K834351 | 000 |