FDA UDI
In Commercial Distribution
🇺🇸 United States
Reinforced Introducer Set for Sensation 7Fr
DI: 10607567106694
·
Model: 0684-00-0403-06
·
DATASCOPE CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reinforced Introducer Set for Sensation 7Fr
- Primary DI
- 10607567106694
- Version / Model
- 0684-00-0403-06
- Catalog Number
- 0684-00-0403-06
- Company Name
- DATASCOPE CORP.
- Labeler DUNS
- 001660786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-14
- Public Version
- 1
- Public Version Date
- 2023-03-22
- Public Version Status
- New
- Public Device Record Key
- cc1fceb0-4e2d-4c23-89b5-1f02e167fce4
Device Description
Reinforced Introducer Set for Sensation 7Fr
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10607567106694 | GS1 |
Customer Contacts
- Phone
- 888-627-8383
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002365 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 7 | French |