90X17 IVF PETRIDISH NONTREATED VENTS
Basic Information
- Brand Name
- 90X17 IVF PETRIDISH NONTREATED VENTS
- Primary DI
- 05713311000052
- Version / Model
- 150360
- Catalog Number
- 150360
- Company Name
- Nunc A/S
- Labeler DUNS
- 305971764
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 8
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- c9fe1c2e-6a29-4f42-b18f-aefabf5667ee
- Distribution End Date
- 2021-12-31
Device Description
Nunc IVF Petri Dish is an injection moulded polystyrene dish. The material is virgin, crystal-grade polystyrene. The dishes are used for preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques, and cell culture. The dishes come in bags of 10 dishes, and each dish has a removable lid of the same virgin polystyrene as the dish itself. The dishes are irradiated in order to obtain sterility with a sterility assurance level of 10E-6. The dishes are designed in such a way that when the lid is mounted on the dish, the dishes can be stacked. The lid is easy to remove by one hand, which eases the use of the dish. The dishes have a flat, optically clear surface for optimum manipulation and observation of ovaries and embryos. The use of the dishes is specific to the procedure used in an IVF clinic. The dish is manually handled, and the only critical thing that it needs to fit into is the heating block. Normally, the heating block is adapted for the dishes. The product is tested for pyrogenicity, and mouse embryo toxicity assay tested. The dishes are shipped in bags of 10 in a box holding 150 dishes. The polystyrene used for the dish and the lid is virgin, crystal-grade polystyrene, which has passed the USP Class VI test for cytotox The use of the products depends on the validated protocols in the individual IVF clinics. Hence no Instruction for Use (IFU) is supplied with the products.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PUD | Labware, Assisted Reproduction, Exempt | 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 | 05713311000052 | GS1 | ||||
| Unit of Use | 15713311000059 | GS1 |
Customer Contacts
- Phone
- +4546312000
- [email protected]