FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Freeman Pancreatic Flexi-Stent Kit
DI: M84963100
·
Model: 6310
·
HOBBS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Freeman Pancreatic Flexi-Stent Kit
- Primary DI
- M84963100
- Version / Model
- 6310
- Catalog Number
- 6310
- 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
- 2026-01-09
- Public Version Status
- Update
- Public Device Record Key
- db63b744-920c-449d-938c-b4c108cb40b9
- Distribution End Date
- 2024-08-29
Device Description
Pancreatic Flexi-Stent Kit includes Stent and Pusher Catheter. This is a single use device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| 42701 | Polymeric pancreatic stent, non-bioabsorbable | A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M84963100 | HIBCC |
Customer Contacts
- Phone
- 8606845875
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K834351 | 000 |