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Migs Kit 4

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
MIGS KIT 4 FDA UDI
Generic Name
Laparoscopic access cannula, single-use FDA UDI
Device Name
Kit Contains: (1) GTB14, Alexis Contained Extraction System, 14cm (1) CNGL3, GelPoint Mini Advanced access platform (3) CFF03, 5x100mm Kii Fios First Entry, Advanced Fixation (1) EB010, Voyant 5mm Fusion Device, 37cm FDA UDI
Model / Reference
GK161 FDA UDI
Description
Kit Contains: (1) GTB14, Alexis Contained Extraction System, 14cm (1) CNGL3, GelPoint Mini Advanced access platform (3) CFF03, 5x100mm Kii Fios First Entry, Advanced Fixation (1) EB010, Voyant 5mm Fusion Device, 37cm FDA UDI

Identifiers

Primary DI / UDI-DI
20607915139166 FDA UDI
FDA Product Code
GCJ FDA UDI
GEI FDA UDI
GMDN Term
Laparoscopic access cannula, single-use FDA UDI

Classification

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

No

FDA UDI

Category: Laparoscopic access cannula, single-useElectrosurgical systemTissue extraction bagLaparoscopic multi-instrument access port, single-use

Migs Kit 4 by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic multi-instrument access port, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA UDI e414b1f8-c025-4cc2-87b4-a1dc60c41b4e 34 fields · synced May 30, 2026