Retrobulbar Needle Atkinson 27G x 38mm
EUDAMEDFDA UDIClass IIa (EU MDR)
by Aktive Srl
Identity
- Trade Name
- Retrobulbar Needle Atkinson 27G x 38mm EUDAMEDFDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Needles and Cannulae / Aghi e Cannule EUDAMEDRetrobulbar Needle Atkinson 27G x 38mm FDA UDI
- Model / Reference
- Needles and Cannulae / Aghi e Cannule EUDAMED1640 EUDAMEDFDA UDI
- Description
- Retrobulbar Needle Atkinson 27G x 38mm FDA UDI
Identifiers
- Catalog Number
- 1640 FDA UDI
- Primary DI / UDI-DI
- 08052276012913 EUDAMEDFDA UDI
- Basic UDI-DI
- 8052276FT0001ID10KM EUDAMED
- Unit of Use DI
- 08056477554838 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Italy 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
No
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 irrigation/infusion/aspiration cannula, non-illuminating, single-use
The Retrobulbar Needle Atkinson 27G x 38mm is a Class IIa medical device designed for implantable use, providing precise and reliable placement of needles and cannulae in the eye. This instrument features advanced sterility, reusability, and ease of use, making it an ideal choice for ophthalmic procedures.
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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 | 8052276FT0001ID10KM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aktive Srl
- EUDAMED SRN
- IT-MF-000007813
Sources (2)
- EUDAMED 0defc7d1-6c2e-4ef3-85c3-816b14ff54fb 61 fields · synced Jul 31, 2026
- FDA UDI c77afba3-c690-41ec-89af-985614a631b7 36 fields · synced May 30, 2026