FDA UDI
Not in Commercial Distribution
🇺🇸 United States
INVOcell Retention Device
DI: 00862190000341
·
Model: P-017
·
INVO BIOSCIENCE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INVOcell Retention Device
- Primary DI
- 00862190000341
- Version / Model
- P-017
- Company Name
- INVO BIOSCIENCE, INC.
- Labeler DUNS
- 829694889
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-02
- Public Version
- 6
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 6f9fd063-1a3a-4585-b0fc-d580b4d6f57b
- Distribution End Date
- 2018-12-31
Device Description
The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone.
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
- No
- 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 | 00862190000341 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN150008 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 77 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from moisture and direct heat