FDA UDI
In Commercial Distribution
🇺🇸 United States
Coil Pusher-16
DI: 08714729158967
·
Model: M0014012160
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Coil Pusher-16
- Primary DI
- 08714729158967
- Version / Model
- M0014012160
- Catalog Number
- M0014012160
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- c084bbaa-af78-47c6-a584-252b27e4d30f
Device Description
Coil Pusher-16
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 |
|---|---|---|---|---|
| KRD | Device, Vascular, for Promoting Embolization | Cardiovascular | 870.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43978 | Embolization implant inserter | A long, thin, manual surgical device intended to advance an embolization implant (e.g. an embolic coil) through the length of an appropriate catheter so that the implant is ready for discharge (implantation) when the catheter has been surgically positioned at the target site in an artery or vein. The inserter, also known as a pusher, is removed prior to discharge of the implant. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729158967 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.016 in Diameter | ||
| Device Size Text, specify | 0.41 mm Diameter | ||
| Device Size Text, specify | 177 cm Length |