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Anodyne Surgical
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 0021Model Anesthesia Needles
Identity
- Trade Name
- Sub Tenon Cannula 21g X 22mm (7/8") curved, tri port EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic needle, single-use FDA UDI
- Device Name
- Sub Tenon Cannula 21g X 22mm (7/8") curved, tri port FDA UDI
- Model / Reference
- 0021 EUDAMEDFDA UDIAnesthesia Needles EUDAMED
- Description
- Sub Tenon Cannula 21g X 22mm (7/8") curved, tri port FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516114835 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840516100003Z EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic needle, single-use
Anodyne Surgical by Psi/Eye-Ko, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic needle, single-use.
- Anaesthetic Needles — STERIMEDIX LIMITED · Class II
- Needle aspiration and injection — Katena Products, Inc. · Class I
- OMNI Edge Surgical System — Sight Sciences, Inc. · Class II
- STERiJECT OPHTHALMIC NEEDLE™ Low Dead Space (LDS) — TSK LABORATORY INTERNATIONAL JAPAN K.K. · Class II
- Disposable Instruments — OASIS Medical, Inc. · Class I
- Anaesthetic Needles — STERIMEDIX LIMITED · Class II
- Needle aspiration and injection — Katena Products, Inc. · Class I
- Anaesthetic Needles — STERIMEDIX LIMITED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Psi/Eye-Ko, Inc.
Sources (2)
- FDA UDI 7ffa275c-5ade-46ff-a21d-ca378c3e5ee4 34 fields · synced Jun 18, 2026
- EUDAMED 4eaa9d7e-01a6-4576-adf9-6f32ac2c516b 61 fields · synced Jun 18, 2026