FDA UDI
In Commercial Distribution
🇺🇸 United States
WATCHMAN FXD Curve™ Access System
DI: 00191506013806
·
Model: M635TU80010
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WATCHMAN FXD Curve™ Access System
- Primary DI
- 00191506013806
- Version / Model
- M635TU80010
- Catalog Number
- M635TU80010
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-10
- Public Version
- 1
- Public Version Date
- 2021-09-20
- Public Version Status
- New
- Public Device Record Key
- 93aa908c-f73d-4e87-9add-0dfaef59cfa5
Device Description
Access Sheath with Dilator
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
- 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
- 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 |
|---|---|---|---|---|
| DQY | Catheter, percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45419 | Cardiac occluder delivery kit | A collection of devices designed to implant a cardiac occluder (not included) for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occluder. The devices are used in the treatment of cardiac disorders that may include atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506013806 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 75 | Centimeter | |
| Lumen/Inner Diameter | 4.2 | Millimeter |