FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cryolock
DI: B056CLRCT1
·
Model: CL-R-CT
·
BIOTECH INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
5
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Basic Information
- Brand Name
- Cryolock
- Primary DI
- B056CLRCT1
- Version / Model
- CL-R-CT
- Catalog Number
- CL-R-CT
- Company Name
- BIOTECH INCORPORATED
- Labeler DUNS
- 080129843
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-12-13
- Public Version
- 4
- Public Version Date
- 2019-06-03
- Public Version Status
- Update
- Public Device Record Key
- 8c06a91e-65a6-4c69-bf20-0906f9f87d37
- Distribution End Date
- 2019-06-01
Device Description
Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage 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
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
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 | B056CLRCT2 | HIBCC | Pack of 50 | 10 | Not in Commercial Distribution | 2019-06-01 |
| Primary | B056CLRCT1 | HIBCC | ||||
| Unit of Use | B056CLRCT0 | HIBCC | ||||
| Package | B056CLRCT5 | HIBCC | BOX | 36 | Not in Commercial Distribution | 2019-06-01 |
Customer Contacts
- Phone
- 1-800-313-7793
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122982 | 000 |