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GelPoint Path Transanal Procedural Pack

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
GelPoint Path Transanal Procedural Pack FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
GelPoint Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation FDA UDI
Model / Reference
TA211 FDA UDI
Description
GelPoint Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation FDA UDI

Identifiers

Primary DI / UDI-DI
20607915139050 FDA UDI
FDA Product Code
GEI FDA UDI
FER FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, 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

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: Endoscopic electrosurgical handpiece/electrode, monopolar, single-useLaparoscopic multi-instrument access port, single-use

GelPoint Path Transanal Procedural Pack 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 397a11cc-0dfe-4794-9d35-cb2f6ac8990b 34 fields · synced Jun 8, 2026