Identity
- Trade Name
- Single Use Professional FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- Aspiration Needle 5mm 32cm contains 25 units FDA UDI
- Model / Reference
- S080 FDA UDI
- Description
- Aspiration Needle 5mm 32cm contains 25 units FDA UDI
Identifiers
- Catalog Number
- S080 FDA UDI
- Primary DI / UDI-DI
- 05055299101339 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 32 Centimeter FDA UDI
Category: Body aspiration needle, single-use
Single Use Professional by Eakin Surgical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body aspiration needle, single-use.
- Arthrex® — Arthrex, Inc. · Class I
- ECOJEKT — H.S. HOSPITAL SERVICE SPA · Class I
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- Echotip — COOK INCORPORATED · Class I
- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
- Invivo — Philips DS North America LLC · Class II
- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- MReye — COOK INCORPORATED · Class II
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
- Eakin Surgical Limited
Sources (1)
- FDA UDI b22db10d-b64b-4964-9a24-07551714e69d 35 fields · synced May 30, 2026