Identity
- Trade Name
- COOK FDA UDI
- Generic Name
- User-induced micropipette FDA UDI
- Model / Reference
- G61015 FDA UDI
Identifiers
- Catalog Number
- K-EBPH-2535 FDA UDI
- Primary DI / UDI-DI
- 00827002610156 FDA UDI
- FDA Product Code
- PUC FDA UDI
- GMDN Term
- User-induced micropipette 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
Yes
FDA UDI
Category: User-induced micropipette
Cook by Cook Vandergrift Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Biopsy Pipette — Vitrolife Sweden AB · Class II
- ICSI Pipette — Vitrolife AB · Class II
- Hatching Pipette — Vitrolife AB · 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
- Cook Vandergrift Inc.
Sources (1)
- FDA UDI a8d99720-b7d5-4803-9c69-280421784cf9 35 fields · synced Jun 8, 2026