FDA UDI
In Commercial Distribution
🇺🇸 United States
SSPC1 Delivery Catheter
DI: 00810024671816
·
Model: 9181
·
CENTERPOINT SYSTEMS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SSPC1 Delivery Catheter
- Primary DI
- 00810024671816
- Version / Model
- 9181
- Company Name
- CENTERPOINT SYSTEMS LLC
- Labeler DUNS
- 117126091
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-21
- Public Version
- 2
- Public Version Date
- 2020-05-28
- Public Version Status
- Update
- Public Device Record Key
- 3054f6c4-02b5-4a06-b6a6-967d7549ff61
Device Description
Catheter and 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
- MR Unsafe
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61501 | Pacing/defibrillation lead delivery catheter | A sterile, non-steerable, thin flexible tube intended to be introduced percutaneously into the cardiac anatomy (e.g., coronary sinus) to provide a conduit for the delivery of a cardiac pacing and/or defibrillation lead (not included). It may include additional synergistic catheters and is intended to be introduced through a separate catheter introducer sheath, which may be included along with additional devices dedicated to catheter introduction/function. It does not contain electrodes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810024671816 | GS1 |
Customer Contacts
- Phone
- 877-848-0828
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190475 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Maximum Compatible Guidewire Outside Diameter: 0.035" | ||
| Device Size Text, specify | Inner Diameter: 6.5F | ||
| Device Size Text, specify | Outer Diameter: 8F | ||
| Catheter Working Length | 40 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store in direct sunlight