Identity
- Trade Name
- NEEDLE, AIR ASPIRATOR 18 GA PEDI W/PINK CAP FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device. FDA UDI
- Model / Reference
- 201015-000 FDA UDI
- Description
- A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 201015-000 FDA UDI
- Primary DI / UDI-DI
- B0662010150000 FDA UDI
- 510(k) Number
- K801393 FDA UDI
- FDA Product Code
- DWS FDA UDI
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.4500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Body aspiration needle, single-use
Needle, Air Aspirator 18 Ga Pedi W/Pink Cap by Novosci Corp. — 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
- Chiba Needle Marked — REMINGTON MEDICAL, INC. · Class I
- 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
Cleared under the same submission
K801393 also covers:
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
- Novosci Corp.
Sources (1)
- FDA UDI bf3222c2-196a-4a1e-9e5a-731f6fa2c895 36 fields · synced Jun 1, 2026