FDA UDI
In Commercial Distribution
🇺🇸 United States
Tendril MRI™
DI: 05414734504683
·
Model: LPA1200M-46
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tendril MRI™
- Primary DI
- 05414734504683
- Version / Model
- LPA1200M-46
- Catalog Number
- LPA1200M-46
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-07
- Public Version
- 7
- Public Version Date
- 2022-02-23
- Public Version Status
- Update
- Public Device Record Key
- e5b86fd2-fde8-4ac4-99e6-4b6af43760eb
Device Description
Pacing Lead
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35223 | Endocardial pacing lead | An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414734504683 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P140033 | 000 |
| P140033 | 006 |
| P140033 | 010 |
| P140033 | 019 |
| P140033 | 023 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 46 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage excursions permitted from 59°- 86° F (15°- 30°C).
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius