Peribulbar Needle [Atkinson] 27g X 22mm (7/8")
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Peribulbar Needle [Atkinson] 27g X 22mm (7/8") EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic needle, single-use FDA UDI
- Device Name
- Peribulbar Needle [Atkinson] 27g X 22mm (7/8") FDA UDI
- Model / Reference
- Anesthesia Needles EUDAMED0001C EUDAMEDFDA UDI
- Description
- Peribulbar Needle [Atkinson] 27g X 22mm (7/8") FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516103228 EUDAMED00840516114583 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
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
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
No
Manufacturing Date
Yes
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Peribulbar Needle [Atkinson] 27g X 22mm (7/8") by Psi/Eye-Ko, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840516100003Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 7a092ee7-1770-41ec-8cd2-efac63468bcd 61 fields · synced Jul 29, 2026
- FDA UDI 63907461-377b-48ae-bddb-4a5d03e34a2a 34 fields · synced May 30, 2026
- EUDAMED e64345c6-f0ca-40b9-b926-9a1b63e38fe9 61 fields · synced Jul 29, 2026