Identity
- Trade Name
- Disposable Instruments FDA UDI
- Generic Name
- Ophthalmic surgical irrigation/infusion/aspiration handle, single-use FDA UDI
- Device Name
- Anterior Chamber Cannula, 30g x 7/8” (0.3 x 22mm), 6mm Bend, Bulk FDA UDI
- Model / Reference
- B-4001-NS FDA UDI
- Description
- Anterior Chamber Cannula, 30g x 7/8” (0.3 x 22mm), 6mm Bend, Bulk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10845819001421 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 comprehensive medical device directory listing for the Disposable Instruments, an Anterior Chamber Cannula. This manual tubular device is designed as an interface between an ophthalmic cannula and associated tubing to facilitate manipulation of the cannula in cataract surgery.
Similar devices
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- 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 bfda7e21-109c-4784-99f0-0afa7a76c6ea 34 fields · synced Jul 8, 2026