FDA UDI
In Commercial Distribution
🇺🇸 United States
VersaCross Transseptal Dilator
DI: 00685447004684
·
Model: VCD85-35-95-D1
·
Baylis Médicale Cie Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VersaCross Transseptal Dilator
- Primary DI
- 00685447004684
- Version / Model
- VCD85-35-95-D1
- Company Name
- Baylis Médicale Cie Inc
- Labeler DUNS
- 249225954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-23
- Public Version
- 5
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- 98f9bc87-28dc-46f6-baa9-c172c7f2755c
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
- 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 |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47492 | Cardiac transseptal access dilator | A device designed to be used with a transseptal vascular guide-catheter (not included) to penetrate the interatrial septum to gain left-heart access during a transseptal catheterization procedure. It is typically a long, thin tube made of plastic that is curved and round-nosed at the distal end for positioning against the atrial septum, and to accommodate in its lumen a Brockenbrough type curved puncture needle (not included). It will typically have a marker (e.g., a hub) to identify the proximal portion of the dilator and to aid placement of the guide-catheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00685447004684 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 8.5 | French | |
| Length | 95 | Centimeter | |
| Device Size Text, specify | Large Curve |