FDA.reportPublic FDA data

Transport Endoscopic Access Device

Primary DI
00860009064706
Brand
Transport Endoscopic Access Device
Company
Usgi Medical, Inc.
Model
Transport Retroflex
Catalog number
118180
Device description
Transport Endoscopic Access Device
Published
2022-12-20
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

Product Codes#

Code, Name table
CodeName
FEDEndoscopic Access Overtube, Gastroenterology-Urology
ODBEndoscopic Contamination Prevention Sheath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
ODBEndoscopic Contamination Prevention SheathGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072405000USGI TRANSPORT ENDOSCOPIC ACCESS DEVICEUsgi Medical2007-09-13FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009064706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009064706008600090647068600090647060860009064706

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel gastrointestinal endoscopic guide, steerableA sterile, steerable, multi-luminal, flexible tube intended to function as a housing for a compatible flexible endoscope and endoscopic tool(s), to facilitate introduction of the endoscope, and provide independent working channels (i.e., not through the endoscope) for the flexible endoscopic tool(s) during procedures of the upper gastrointestinal (GI) tract (e.g., placement of tissue anchors). It includes proximal ports and controls to steer the distal end, and may assist in the repeated advancement and withdrawal of the endoscope or endoscopic devices. This is a single-use device.

Regulatory Flags#

DUNS number
112331090
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009064713g-Cath Suture Anchor Delivery Catheterg-Cath EZ2081002022-12-20
00860009064720g-Prox EZ Endoscopic Grasperg-Prox EZ-162082002022-12-20
00860009064737g-Prox EZ Endoscopic Grasperg-Prox EZ-332082202022-12-20
00860009064744g-Lix Tissue Grabberg-Lix3010102022-12-20
00860009064751Transport Endoscopic Access DeviceTransport-R5001002022-12-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
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