NRG RF Transseptal Kit
- Primary DI
- 00685447014409
- Brand
- NRG RF Transseptal Kit
- Company
- Baylis Médicale Cie Inc
- Model
- NTK-710-8545N
- Device description
- 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath
- Published
- 2022-07-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| DQY | Catheter, Percutaneous |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00685447014409 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00685447014409 | 00685447014409 | 685447014409 | 0685447014409 |
GMDN Terms
| Term | Definition |
|---|
| Cardiac transseptal access set | A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 249225954
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00685447019558 | VersaCross™ Large Access Solution | VLAK0102 | VLAK0102 | 2025-02-25 |
| 00685447019565 | VersaCross™ Large Access Solution | VLAK0109 | VLAK0109 | 2025-02-25 |
| 00685447019572 | VersaCross™ Large Access Solution | VLAK0110 | VLAK0110 | 2025-02-25 |
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| 00685447019596 | VersaCross™ Large Access Solution | VLAK0114 | VLAK0114 | 2025-02-25 |
| 00685447019602 | VersaCross™ Steerable Access Solution | VSTK0102 | VSTK0102 | 2025-02-25 |
| 00685447019619 | VersaCross™ Steerable Access Solution | VSTK0103 | VSTK0103 | 2025-02-25 |
| 00685447019626 | VersaCross™ Steerable Access Solution | VSTK0104 | VSTK0104 | 2025-02-25 |
| 00685447019633 | VersaCross™ Steerable Access Solution | VSTK0106 | VSTK0106 | 2025-02-25 |
| 00685447019640 | VersaCross™ Steerable Access Solution | VSTK0114 | VSTK0114 | 2025-02-25 |
| 00685447019657 | VersaCross™ Steerable Access Solution | VSTK0115 | VSTK0115 | 2025-02-25 |
| 00685447019664 | VersaCross™ Steerable Access Solution | VSTK0116 | VSTK0116 | 2025-02-25 |
| 00685447019671 | VersaCross™ Steerable Access Solution | VSTK0117 | VSTK0117 | 2025-02-25 |
| 00685447019688 | VersaCross™ Steerable Access Solution | VSTK0118 | VSTK0118 | 2025-02-25 |
| 00685447019695 | VersaCross™ Steerable Access Solution | VSTK0120 | VSTK0120 | 2025-02-25 |
Other Devices Sharing Product Codes
baylismedical.com