FDA UDI
In Commercial Distribution
🇺🇸 United States
Axios™
DI: 00191506008093
·
Model: M00553690
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Axios™
- Primary DI
- 00191506008093
- Version / Model
- M00553690
- Catalog Number
- M00553690
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-27
- Public Version
- 1
- Public Version Date
- 2021-06-04
- Public Version Status
- New
- Public Device Record Key
- 8a961108-37a3-4ddf-8d73-61d86ec03bc2
Device Description
Stent and Electrocautery - Enhanced Delivery System
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| PCU | Pancreatic stent, covered, metallic, removable | Gastroenterology, Urology | 876.5015 | 2 |
| KNS | Unit, electrosurgical, endoscopic (with or without accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62611 | Implantable transenteric drainage tube | A non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage. It is a flanged stent-like structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone). It is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices to assist implantation, with or without electrosurgical functionality, may be included with the device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506008093 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Diameter | 8 | Millimeter | |
| Stent Length | 8 | Millimeter |