FDA.reportPublic FDA data

g-Prox EZ Endoscopic Grasper

Primary DI
00860009064720
Brand
g-Prox EZ Endoscopic Grasper
Company
Usgi Medical, Inc.
Model
g-Prox EZ-16
Catalog number
208200
Device description
g-Prox EZ Endoscopic Grasper 16
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
HETLaparoscope, Gynecologic (And Accessories)
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
OCZEndoscopic Grasping/Cutting Instrument, Non-PoweredGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103688000G-PROX EZ ENDOSCOPIC GRASPERUsgi Medical2011-01-14OCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009064720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009064720008600090647208600090647200860009064720

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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
00860009064706Transport Endoscopic Access DeviceTransport Retroflex1181802022-12-20
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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