FDA UDI
In Commercial Distribution
🇺🇸 United States
The Magnet™
DI: 08714729724940
·
Model: H74908966050
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- The Magnet™
- Primary DI
- 08714729724940
- Version / Model
- H74908966050
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- af1379e0-1ba3-4131-986c-78934365ea25
Device Description
Exchange 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
- 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 |
|---|---|---|---|---|
| DQX | WIRE, GUIDE, CATHETER | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61768 | Catheter-exchange guidewire holder | A sterile hand-held device intended for use during guidewire-assisted intravascular interventional procedures [e.g., percutaneous transluminal coronary angioplasty (PTCA)] to facilitate the exchange of one catheter for another (e.g., coronary angioplasty balloon catheter) while maintaining the position of the guidewire. It consists of a clip for mechanical attachment to part of the catheterization device set, and a magnetic channel through which the catheter/guidewire is passed to enable removal of the catheter while the metal guidewire is magnetically held in place. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729008828 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08714729724940 | GS1 |