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Rocket

FDA UDI

by Rocket Medical Plc

Identity

Trade Name
Rocket FDA UDI
Generic Name
X-ray contrast medium, inhaled gas FDA UDI
Device Name
Rocket Microsyringe for Embryo Transfer FDA UDI
Model / Reference
R57596 FDA UDI
Description
Rocket Microsyringe for Embryo Transfer FDA UDI

Identifiers

Catalog Number
R57596 FDA UDI
Primary DI / UDI-DI
05055270914224 FDA UDI
510(k) Number
K994327 FDA UDI
GMDN Term
X-ray contrast medium, inhaled gas FDA UDI

Classification

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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Total Volume — 0.3 Milliliter FDA UDI

Category: X-ray contrast medium, inhaled gas

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

Cleared under the same submission

K994327 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rocket Medical Plc

Sources (1)

  • FDA UDI 699ac2e6-02a5-4198-8064-2494e3c2f594 38 fields · synced May 30, 2026