Identity
- Trade Name
- V-ICSIPET BLASTOMERE BIOPSY FDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- 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 BLASTOMERE BIOPSY pipettes are for the collection of blastomeres for subsequent preimplantation genetic diagnosis. FDA UDI
- Model / Reference
- V-ICSIPET Blastomere Biopsy 35 FDA UDI
- 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 BLASTOMERE BIOPSY pipettes are for the collection of blastomeres for subsequent preimplantation genetic diagnosis. FDA UDI
Identifiers
- Catalog Number
- V-BBP-V1-35 FDA UDI
- Primary DI / UDI-DI
- 04260531790887 FDA UDI
- FDA Product Code
- PUC FDA UDI
- GMDN Term
- Assisted reproduction microtool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assisted reproduction microtool
V-Icsipet Blastomere Biopsy by VITROMED GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ASTEC — ASTEC BIO USA INC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- VITROMED GmbH
Sources (1)
- FDA UDI ca9343ba-50d4-4bea-af28-4bc636e948bb 34 fields · synced Jun 8, 2026