INVOcell Culture Device
- Primary DI
- 00862190000334
- Brand
- INVOcell Culture Device
- Company
- INVO BIOSCIENCE, INC.
- Model
- FG-002
- Device description
- The INVOcell Culture Device is a three-part assembly enclosed in two separate packages. The inner vessel holds culture medium, eggs and sperm, or ICSI fertilized embryos. In an INVOcell procedure, the inner vessel is placed into the outer rigid shell, which provides additional resistance to contamination. Following the loading of gametes or embryos, the INVOcell Culture Device is assembled and placed in the vaginal cavity to allow for embryo development.
- Published
- 2017-05-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| OYO | Culture, Intravaginal, Assisted Reproduction |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OYO | Culture, Intravaginal, Assisted Reproduction | Obstetrics/Gynecology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| DEN150008 | 000 | INVOcell | Invo Bioscience | 2015-11-02 | OYO |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00862190000334 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00862190000334 | 00862190000334 | 862190000334 | 0862190000334 |
GMDN Terms
| Term | Definition |
|---|
| Assisted reproduction procedure dish | A sterile container intended for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store away from moisture and direct heat |
| Storage Environment Temperature | 0 Degrees Fahrenheit | 77 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 829694889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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