LifeGlobal® GPS® Dishware

FDA UDI

Class II (US FDA UDI)

by LifeGlobal Group, LLC

Identity

Trade Name: LifeGlobal® GPS® Dishware FDA UDI
Generic Name: Assisted reproduction procedure dish FDA UDI
Device Name: Special GPS Dish, 38mm (1 sleeve of 10) FDA UDI
Model / Reference: SP38-010 FDA UDI
Description: Special GPS Dish, 38mm (1 sleeve of 10) FDA UDI

Identifiers

Catalog Number: SP38-010 FDA UDI
Primary DI / UDI-DI: 00815965022314 FDA UDI
510(k) Number: K080395 FDA UDI
FDA Product Code: MQK FDA UDI
GMDN Term: Assisted reproduction procedure dish FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6160 FDA UDI
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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Assisted reproduction procedure dish

LifeGlobal® GPS® Dishware by LifeGlobal Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K080395 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 II	Pending data

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Manufacturer

Manufacturer: LifeGlobal Group, LLC

Sources (1)

FDA UDI 62ed2dbb-fafb-485f-ba1e-9353f01d9c0e 37 fields · synced Jun 9, 2026