Identity
- Trade Name
- Disposable Instruments FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Irrigating Cystotome, Angled, 27g x 5/8” (0.4 x 16mm) FDA UDI
- Model / Reference
- B-4017N-NSC FDA UDI
- Description
- Irrigating Cystotome, Angled, 27g x 5/8” (0.4 x 16mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10845819006297 FDA UDI
- FDA Product Code
- HNY FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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
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: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
A comprehensive medical device for ophthalmic irrigation, infusion, and aspiration cannulas. Discover its features, compliance, and usage instructions.
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar 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
- OASIS Medical, Inc.
Sources (1)
- FDA UDI b1f84fc4-3af4-46cc-83c1-754e03b9d01a 34 fields · synced Jul 8, 2026