FDA UDI
In Commercial Distribution
🇺🇸 United States
EP Recording Catheter
DI: 00811331011852
·
Model: CF-D7-AAA-NSDA
·
Tz Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EP Recording Catheter
- Primary DI
- 00811331011852
- Version / Model
- CF-D7-AAA-NSDA
- Company Name
- Tz Medical, Inc.
- Labeler DUNS
- 793149709
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-21
- Public Version
- 1
- Public Version Date
- 2023-09-29
- Public Version Status
- New
- Public Device Record Key
- f0b3435b-05f1-435c-b4e1-3e14e6cb87d0
Device Description
EP Recording Catheter 14 pole, fixed curve
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | 870.1220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48015 | Cardiac mapping/endocardial-injection catheter | A sterile, steerable, thin, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to relay information to an external cardiac mapping system to create a three-dimensional (3-D) electromechanical reconstruction map of the heart chamber. The device also incorporates a small hollow needle intended for targeted delivery of diagnostic and therapeutic agents into the myocardium. The device is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811331011852 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021421 | 000 |