Migs Kit 3

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: MIGS KIT 3 FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: Kit contains: (1) GTB17, Alexis Contained Extraction System, 17cm (1) C0R47, 12x100mm Kii Balloon Blunt Tip System (3) CFF03, 5x100mm Kii Fios First Entry, Advanced Fixation (1) EB010, Voyant 5mm Fusion Device, 37cm FDA UDI
Model / Reference: GK160 FDA UDI
Description: Kit contains: (1) GTB17, Alexis Contained Extraction System, 17cm (1) C0R47, 12x100mm Kii Balloon Blunt Tip System (3) CFF03, 5x100mm Kii Fios First Entry, Advanced Fixation (1) EB010, Voyant 5mm Fusion Device, 37cm FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915139159 FDA UDI
FDA Product Code: GEI FDA UDI
GCJ FDA UDI
GMDN Term: Laparoscopic access cannula, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
876.1500 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

Yes

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: Laparoscopic access cannula, single-use Electrosurgical system Tissue extraction bag

Migs Kit 3 by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Applied Medical Resources Corp.

Sources (1)

FDA UDI 6756ec74-4f06-4695-bb54-3476c3ecdf29 34 fields · synced May 31, 2026