FDA UDI
In Commercial Distribution
🇺🇸 United States
INVOcell Culture Device
DI: 00862190000334
·
Model: FG-002
·
INVO BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INVOcell Culture Device
- Primary DI
- 00862190000334
- Version / Model
- FG-002
- Company Name
- INVO BIOSCIENCE, INC.
- Labeler DUNS
- 829694889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-09
- Public Version
- 5
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- de5832ae-c2f9-40b8-9082-03818bf12804
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.
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 |
|---|---|---|---|---|
| OYO | Culture, Intravaginal, Assisted Reproduction | Obstetrics/Gynecology | 884.6165 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56648 | Assisted reproduction procedure dish | A container intended exclusively 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 used in assisted reproduction clinics. It is available in a variety of shapes and sizes (e.g., multi-well dishes, Petri dishes, ICSI dishes) and is typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862190000334 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN150008 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from moisture and direct heat
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit