FDA UDI
In Commercial Distribution
🇺🇸 United States
Archimedes Biodegradable Pancreatic Stent
DI: 00850078427175
·
Model: BPS26060FUS
·
Q3 Medical USA LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Archimedes Biodegradable Pancreatic Stent
- Primary DI
- 00850078427175
- Version / Model
- BPS26060FUS
- Catalog Number
- BPS26060FUS
- Company Name
- Q3 Medical USA LLC
- Labeler DUNS
- 117150469
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-25
- Public Version
- 1
- Public Version Date
- 2025-12-03
- Public Version Status
- New
- Public Device Record Key
- 70c9977f-4ee0-45d4-be59-1556e59b6496
Device Description
The ARCHIMEDESTM Biodegradable Pancreatic Stent is a single use, sterile, biodegradable stent implant intended for use in the pancreatic duct. The device is intended to be delivered endoscopically through the working channel of a duodenoscope.
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
- 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 | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63968 | Polymeric biliary/pancreatic stent | A sterile bioabsorbable tubular device intended to be implanted in an obstructed/stenosed biliary and pancreatic duct (i.e., a dual-purpose device capable of implantation at either anatomy) to temporarily maintain luminal patency. It is in the form of a non-expandable tube (not mesh-like) which may include retention barbs at each end, and is made of a synthetic polymer(s) [e.g., polydioxanone, polyurethane] which will gradually disintegrate(s) following implantation; it may be radiopaque (e.g., include barium sulfate). 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 | 00850078427175 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243412 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep in a cool, dark and dry place.