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Peribulbar Needle [Atkinson] 27g X 32mm (1 1/4")
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0001FModel Anesthesia Needles
Identity
- Trade Name
- Peribulbar Needle [Atkinson] 27g X 32mm (1 1/4") EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic needle, single-use FDA UDI
- Device Name
- Peribulbar Needle [Atkinson] 27g X 32mm (1 1/4") FDA UDI
- Model / Reference
- Anesthesia Needles EUDAMED0001F EUDAMEDFDA UDI
- Description
- Peribulbar Needle [Atkinson] 27g X 32mm (1 1/4") FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516102146 EUDAMED00840516114590 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
EUDAMEDEUDAMEDFDA 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
Peribulbar Needle [Atkinson] 27g X 32mm (1 1/4") by Psi/Eye-Ko, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 1f5b2a16-0e64-44ea-bfc1-5748fb715b06 61 fields · synced Jul 18, 2026
- FDA UDI bc9a02ac-b082-44e9-973f-146eceb27b48 34 fields · synced May 30, 2026
- EUDAMED edd28f88-67ee-4631-92bb-fd1c83de984f 61 fields · synced Jul 10, 2026