FDA UDI
In Commercial Distribution
🇺🇸 United States
CryoTip®
DI: 00893727002118
·
Model: 40709-Pack
·
FUJIFILM IRVINE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- CryoTip®
- Primary DI
- 00893727002118
- Version / Model
- 40709-Pack
- Catalog Number
- 40709
- Company Name
- FUJIFILM IRVINE SCIENTIFIC, INC.
- Labeler DUNS
- 057475246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 4
- Public Version Date
- 2019-02-13
- Public Version Status
- Update
- Public Device Record Key
- 8d687168-1a9d-41ca-b440-af402a56e51e
Device Description
CryoTip
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
- Yes
- 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 |
|---|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | Obstetrics/Gynecology | 884.6130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57834 | Assisted reproduction cryotube | A sterile container (a dedicated sealable tube) intended for transport, storage and preparation of biological samples of human origin used in assisted reproduction techniques (ART), e.g., embryos. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF) and ART clinics. Its main application being to hold biological materials when stored in a frozen state at temperatures below -130 Celsius (e.g., stored in the gas phase above the liquid nitrogen (LN2) at temperatures around -178 C to -150 C). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00893727002118 | GS1 | ||||
| Unit of Use | 10893727002115 | GS1 |
Customer Contacts
- Phone
- 8004375706
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041562 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius