Micro well group culture dish, 9-well
Basic Information
- Brand Name
- Micro well group culture dish, 9-well
- Primary DI
- 05712714666049
- Version / Model
- 16604
- Catalog Number
- 16604
- Company Name
- Vitrolife A/S
- Labeler DUNS
- 308547608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-21
- Public Version
- 5
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- b3281f13-59f6-4a78-ae9b-df66bb48c615
Device Description
The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture. The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6). Indications for Use / Intended Use: For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 05712714666049 | GS1 | ||||
| Package | 15712714666046 | GS1 | Card board box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +4570230500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150756 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 25 Degrees Celsius