Rocket

FDA UDI

by Rocket Medical Plc

Identity

Trade Name: Rocket FDA UDI
Generic Name: IVF oocyte aspiration needle, single-use FDA UDI
Device Name: Rocket Double Lumen Aspiration Needle FDA UDI
Model / Reference: R57611 FDA UDI
Description: Rocket Double Lumen Aspiration Needle FDA UDI

Identifiers

Catalog Number: R57611 FDA UDI
Primary DI / UDI-DI: 05055270914439 FDA UDI
510(k) Number: K000205 FDA UDI
GMDN Term: IVF oocyte aspiration needle, single-use FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 1.651 Millimeter FDA UDI
Length — 32.0 Centimeter FDA UDI

Category: IVF oocyte aspiration needle, single-use

Rocket by Rocket Medical Plc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as IVF oocyte aspiration needle, single-use.

Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class II
Follicle Aspiration Set Single Lumen, Luer — Vitrolife Sweden AB · Class II
Cook — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class II
Follicle Aspiration Set Double Lumen — Vitrolife Sweden AB · Class II
16G Wallace Dual Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
17G Wallace Dual Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
18G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II
16G Wallace Single Lumen Oocyte Recovery Set — CooperSurgical, Inc. · Class II

Cleared under the same submission

K000205 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	N/A	Pending data

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Manufacturer

Manufacturer: Rocket Medical Plc

Sources (1)

FDA UDI 4c24d7c2-e61a-4cae-b66c-dfb00699e6b7 38 fields · synced May 30, 2026