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Bi-Manual, 23 Gauge, Curved 0.3mm Single Port, Aspiration Capsule Polisher
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Bi-Manual, 23 Gauge, Curved 0.3mm Single Port, Aspiration Capsule Polisher FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Model / Reference
- Bi-98323 FDA UDI
Identifiers
- Catalog Number
- Bi-98323 FDA UDI
- Primary DI / UDI-DI
- 00844685002832 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Bi-Manual, 23 Gauge, Curved 0.3mm Single Port, Aspiration Capsule Polisher by Microsurgical Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable.
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- PANNU VISCO ASPIRATING CANNULA 22/23GA — Katena Products, Inc. · Class I
- Appasamy — APPASAMY ASSOCIATES PRIVATE LIMITED · Class IIa
- MR PHACO — Crestpoint Management Ltd. · Class I
- Mclntyre Anterior Chamber Cannula Angled Gauge 30 Stainless Steel — SURTEX INSTRUMENTS LTD · Class IIa
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Microsurgical Technology, Inc.
Sources (1)
- FDA UDI 2f193334-9a4e-4c0c-a9a6-5dca2ba59621 33 fields · synced May 30, 2026