FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cryotec
DI: 04589700010206
·
Model: TEC104W
·
REPROLIFE INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- Cryotec
- Primary DI
- 04589700010206
- Version / Model
- TEC104W
- Catalog Number
- TEC104W
- Company Name
- REPROLIFE INC.
- Labeler DUNS
- 691176883
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 5
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 5670f33c-0129-4611-94df-a3fb64522d5c
- Distribution End Date
- 2017-08-31
Device Description
Kitazato Cryotec (4 pieces) (White)
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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| MQK | Labware, Assisted Reproduction | Obstetrics/Gynecology | 884.6160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48007 | Tissue cryostorage straw | A long, thin, tubular sterile device in the form of a straw used for the placement and storage of human biological samples such as embryos, oocytes, sperm, and human tissue in liquid nitrogen (LN2) or in the volumes of vapour phase LN2 in a liquid nitrogen container. It is made of materials to withstand storage in LN2 and is available in a variety of designs that may include a sliding plug or a permeable membrane plug to hold the sample. The sample is inserted into one end of the device and both ends are sealed, typically by using a thermal sealing device, creating an airtight seal to protect the sample from direct contact with the LN2. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04589700010206 | GS1 | ||||
| Unit of Use | 45897000120011 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162051 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 20 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 20 Degrees Celsius