Identity
- Trade Name
- ASTEC FDA UDI
- Generic Name
- Assisted reproduction microtool FDA UDI
- Device Name
- 5.5-6µm OD, 4.0µm ID, 20-25° Tip Bevel, 20° Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spiked FDA UDI
- Model / Reference
- ICSI Injection Pipette FDA UDI
- Description
- 5.5-6µm OD, 4.0µm ID, 20-25° Tip Bevel, 20° Neck Angle, 1mm Tip to Elbow, Smooth Jaw, Spiked FDA UDI
Identifiers
- Catalog Number
- AI4020-YL FDA UDI
- Primary DI / UDI-DI
- B951AI4020YL1 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
Astec by Astec Bio Usa Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RI Pipettes — Research Instruments , Ltd. · Class II
- TPC — CooperSurgical, 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
- Astec Bio Usa Inc
Sources (1)
- FDA UDI a2273418-76ba-473e-abdb-02c9028e025f 35 fields · synced May 30, 2026