FDA UDI
In Commercial Distribution
🇺🇸 United States
MOCK CATHETER
DI: 03700111400139
·
Model: MOCK CATHETER
·
LABORATOIRE CCD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MOCK CATHETER
- Primary DI
- 03700111400139
- Version / Model
- MOCK CATHETER
- Catalog Number
- 1322901
- Company Name
- LABORATOIRE CCD
- Labeler DUNS
- 381633924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-05
- Public Version
- 1
- Public Version Date
- 2023-12-13
- Public Version Status
- New
- Public Device Record Key
- be51dd60-576b-4b6f-8459-95cd83ccc943
Device Description
Catheter for embryo transfer trial
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
- Yes
- 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 | 03700111425132 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 03700111400139 | GS1 |
Customer Contacts
- Phone
- +33(0)344266346
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Length | 20.7 | Centimeter | |
| Outer Diameter | 0.16 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.