FDA UDI
In Commercial Distribution
🇺🇸 United States
Kitazato ET Catheter Type5-v2 EC-PRO Stylet
DI: 04580303269794
·
Model: 294020 Type5-2 EC-PRO Stylet
·
KITAZATO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Kitazato ET Catheter Type5-v2 EC-PRO Stylet
- Primary DI
- 04580303269794
- Version / Model
- 294020 Type5-2 EC-PRO Stylet
- Catalog Number
- 294020
- Company Name
- KITAZATO CORPORATION
- Labeler DUNS
- 711091157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-07
- Public Version
- 5
- Public Version Date
- 2023-08-07
- Public Version Status
- Update
- Public Device Record Key
- ea8818ea-dc06-4870-82d5-9a7d8bf813cd
Device Description
4.7Fr EC-PRO Soft Stylet for 190mm Outer Guide
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
- Yes
- 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 |
|---|---|---|---|---|
| MQF | CATHETER, ASSISTED REPRODUCTION | Obstetrics/Gynecology | 884.6110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45846 | Assisted reproduction transfer catheter/set | A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14580303269791 | GS1 | 10 | Not in Commercial Distribution | 2023-01-18 | |
| Primary | 04580303269794 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162878 | 000 |