FDA UDI
In Commercial Distribution
🇺🇸 United States
MUCAT® STERILE
DI: 03700111400740
·
Model: MUCAT® STERILE
·
LABORATOIRE CCD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MUCAT® STERILE
- Primary DI
- 03700111400740
- Version / Model
- MUCAT® STERILE
- Catalog Number
- 110600S
- 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
- 27cddd63-b6ca-46b0-a474-cb05c453c95d
Device Description
Device for cervical mucus aspiration
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 |
|---|---|---|---|---|
| HDR | CAP, CERVICAL | Obstetrics/Gynecology | 884.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47070 | Cervical aspiration catheter | A semi-rigid, sterile, tube designed to aspirate cervical mucous, typically for the evaluation of infertility. It is used to obtain cervical mucous samples for post-coital determination of spermatic hostility; it may also be used to remove a viscous mucous barrier prior to intrauterine insemination, embryo transfer, or other transcervical procedures. The tube usually contains a rigid inner tube with a plunger that is positioned near the distal end; once in situ, the plunger is slowly withdrawn, creating a suction that draws mucous into the tube. The mucous is typically expelled onto a microscope slide for examination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700111425743 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 03700111400740 | GS1 |
Customer Contacts
- Phone
- +33(0)344266379
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.26 | Centimeter | |
| Catheter Length | 26.4 | 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.