FDA UDI
In Commercial Distribution
🇺🇸 United States
Geri Dish
DI: 09348265003017
·
Model: GERI-DSH-20
·
GENEA BIOMEDX PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Geri Dish
- Primary DI
- 09348265003017
- Version / Model
- GERI-DSH-20
- Company Name
- GENEA BIOMEDX PTY LTD
- Labeler DUNS
- 752103403
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-08
- Public Version
- 5
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 3930cb5b-742b-4afa-8ab8-bdc7d23f9290
Device Description
The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used only with the Geri Embryo Incubator.
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 |
|---|---|---|---|---|
| MQK | Labware, Assisted Reproduction | Obstetrics/Gynecology | 884.6160 | 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 |
|---|---|---|---|---|---|---|
| Package | 29348265003011 | GS1 | 24 | In Commercial Distribution | ||
| Package | 19348265003014 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 09348265003017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171736 | 000 |