FDA UDI
In Commercial Distribution
🇺🇸 United States
V-ICSIPET INJECTION
DI: 04260531790924
·
Model: V-ICSIPET Injection without Spike 20
·
VITROMED GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- V-ICSIPET INJECTION
- Primary DI
- 04260531790924
- Version / Model
- V-ICSIPET Injection without Spike 20
- Catalog Number
- V-INJ-V1-20
- Company Name
- VITROMED GmbH
- Labeler DUNS
- 342250668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-03-01
- Public Version
- 1
- Public Version Date
- 2022-03-09
- Public Version Status
- New
- Public Device Record Key
- 46204b0e-8217-4f67-8591-a8050d39906d
Device Description
V-ICSIPET is a borosilicate glass micropipette for use in assisted reproduction. The pipettes are available with different tips, inner diameters and angles. V-ICSIPET pipettes for the manipulation of cells with the help of a micromanipulator. For intracytoplasmic injection (ICSI) of a single sperm into the oocyte (with and without spike).
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
- Yes
- 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 |
|---|---|---|---|---|
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | Obstetrics/Gynecology | 884.6130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46553 | Assisted reproduction microtool | A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04260531791181 | GS1 | ||||
| Primary | 04260531790924 | GS1 |