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Alexis Contained Extraction System with GelPOINT Mini Advanced Access Platform

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
Alexis Contained Extraction System with GelPOINT Mini Advanced Access Platform FDA UDI
Generic Name
Laparoscopic multi-instrument access port, single-use FDA UDI
Device Name
Kit Includes: GTB17, ALEXIS CONTAINED EXT SYS 5BX CNGL3, GelPOINT Mini ADV ACCESS PLATFORM FDA UDI
Model / Reference
GTM17 FDA UDI
Description
Kit Includes: GTB17, ALEXIS CONTAINED EXT SYS 5BX CNGL3, GelPOINT Mini ADV ACCESS PLATFORM FDA UDI

Identifiers

Primary DI / UDI-DI
20607915135700 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscopic multi-instrument access port, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tissue extraction bagLaparoscopic multi-instrument access port, single-use

Alexis Contained Extraction System with GelPOINT Mini Advanced Access Platform by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID

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 874cf815-d359-4474-b65a-e9be8771050b 34 fields · synced May 31, 2026