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GelPOINT Path Transanal Access Platform

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
GelPOINT Path Transanal Access Platform FDA UDI
Generic Name
Laparoscopic multi-instrument access port, single-use FDA UDI
Device Name
Transanal Access Platform with Insufflation Stabilization Bag FDA UDI
Model / Reference
CNB10 FDA UDI
Description
Transanal Access Platform with Insufflation Stabilization Bag FDA UDI

Identifiers

Primary DI / UDI-DI
00607915137915 FDA UDI
FDA Product Code
FER 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

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

Dimensions & Sizes

Size
Length — 4 Centimeter FDA UDI

Category: Laparoscopic multi-instrument access port, single-use

GelPOINT Path Transanal Access Platform 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 525bea45-631a-46e7-8275-e8fc66153a98 35 fields · synced Jun 8, 2026