FDA.reportPublic FDA data

GelPOINT® Path Transanal Access Platform

Primary DI
00607915134440
Brand
GelPOINT® Path Transanal Access Platform
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
CNO11
Device description
Transanal Access Platform
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FERAnoscope And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915134447PackageGS11In Commercial Distribution
00607915134440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791513444710607915134447
00607915134440006079151344406079151344400607915134440

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic multi-instrument access port, single-useA sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19

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Primary DI, Brand, Company table
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08051887044733THD N-Ano anoscopeTHD SPAFER2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAFER2025-03-14
08051887044771THD N-ano anoscopeTHD SPAFER2025-03-14
18051887044730THD N-Ano anoscopeTHD SPAFER2025-03-14
18051887044754THD N-Ano AnoscopeTHD SPAFER2025-03-14
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