FDA.reportPublic FDA data

Pathfinder® Endoscope Overtube

Primary DI
00850006222117
Brand
Pathfinder® Endoscope Overtube
Company
NEPTUNE MEDICAL INC.
Model
GI 110160-2
Catalog number
GI 110160-2
Published
2021-06-07
Public version status
New
Distribution status
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211301000Pathfinder Endoscope OvertubeNeptune Medical, Inc.2021-05-28FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006222117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006222117008500062221178500062221170850006222117

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic overtube, single-useA tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length100Centimeter
Length110Centimeter
Outer Diameter18.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8882028401info@neptunemedical.com

Regulatory Flags#

DUNS number
075588994
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006222032Pathfinder® Endoscope CapGI EC-0412-1GI EC-0412-12021-06-02
00850006222322Pathfinder® CR SystemGI 014CR-12024-07-09
00850006222025Pathfinder® Endoscope Overtube with BalloonGI 110140B-12023-11-20
00850006222124Pathfinder® Endoscope Overtube with BalloonGI 085140B-1GI 110140B-12023-11-20
00850006222049Pathfinder® Endoscope OvertubeGI 065110-2GI 065110-22021-08-31
00850006222056Pathfinder® Endoscope OvertubeGI 085110-2GI 085110-22021-08-31
00850006222063Pathfinder® Endoscope OvertubeGI 145110-2GI 145110-22021-08-31
00850006222070Pathfinder® Endoscope OvertubeGI 065140-2GI 065140-22021-06-07
00850006222087Pathfinder® Endoscope OvertubeGI 110140-2GI 110140-22021-06-07
00850006222094Pathfinder® Endoscope OvertubeGI 065160-2GI 065160-22021-06-07
00850006222100Pathfinder® Endoscope OvertubeGI 085160-2GI 085160-22021-06-07
00850006222018PathfinderGI 085140-2GI 085140-22021-01-28
00850006222001Pathfinder®GI 085140GI 0851402020-07-20

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