Identity
- Trade Name
- Disposable Instruments FDA UDI
- Generic Name
- Ophthalmic surgical irrigation/infusion/aspiration handle, single-use FDA UDI
- Device Name
- Olive Tip Capsule Polisher, 25g x 1”, Angled FDA UDI
- Model / Reference
- B-4027E-NSC FDA UDI
- Description
- Olive Tip Capsule Polisher, 25g x 1”, Angled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10845819006334 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic surgical irrigation/infusion/aspiration handle, single-use 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Ophthalmic surgical irrigation/infusion/aspiration handle, single-use
A hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula.
Similar devices
Also classified as Ophthalmic surgical irrigation/infusion/aspiration handle, single-use.
- VIA360 Surgical System — NEW WORLD MEDICAL, INCORPORATED · Class II
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Backflush Aspiration Handpieces — STERIMEDIX LIMITED · Class II
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Walcott Rx Products — Psi/Eye-Ko, Inc. · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
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
- OASIS Medical, Inc.
Sources (1)
- FDA UDI 90bcf7a3-0aa5-4652-9f54-0ee9b761c9b5 34 fields · synced Oct 7, 2026