FDA UDI
In Commercial Distribution
🇺🇸 United States
CryotopUS-scoop(Y)
DI: 04582231462889
·
Model: CryotopUS-scoop(Y)
·
KITAZATO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CryotopUS-scoop(Y)
- Primary DI
- 04582231462889
- Version / Model
- CryotopUS-scoop(Y)
- Catalog Number
- 81199
- Company Name
- KITAZATO CORPORATION
- Labeler DUNS
- 711091157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-01
- Public Version
- 3
- Public Version Date
- 2023-05-31
- Public Version Status
- Update
- Public Device Record Key
- f21ef9fa-35d0-475c-8f37-66a9ce7476b4
Device Description
Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
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
- Yes
- 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 |
|---|---|---|---|---|
| 47446 | Assisted reproduction vitrification carrier | A sterile, plastic device used during an assisted reproduction vitrification (cryopreservation) procedure to hold a small volume of vitrification media containing a biological specimen (e.g., egg, embryo) to vitrify (cryopreserve) the specimen, thereby avoiding specimen immersion/contact with LN2. The vitrification process may involve the distal tip/specimen being brought into contact with the surface of a vitrification block [a highly-conductive mass of metal semi-submersed in a liquid nitrogen (LN2) bath]. The device with vitrified specimen is then stored in an LN2 tank, and subsequently transferred into a warming medium to recover the specimen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14582231462886 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04582231462889 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181469 | 000 |