Identity
- Trade Name
- Intelligent ICSI Micropipette FDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- Micropipette, ICSI, Feature Type 3, 4.5µm FDA UDI
- Model / Reference
- IC.3.45.xx.A FDA UDI
- Description
- Micropipette, ICSI, Feature Type 3, 4.5µm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858604006320 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
Yes
FDA UDI
Category: Assisted reproduction microtool
Intelligent ICSI Micropipette by HAMILTON THORNE, Inc. — 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
- HAMILTON THORNE, Inc.
Sources (1)
- FDA UDI ecb50b45-3e07-4868-92c4-a1d5cec2821e 33 fields · synced May 31, 2026