FDA.reportPublic FDA data

g-Lix Tissue Grabber

Primary DI
00860009064744
Brand
g-Lix Tissue Grabber
Company
Usgi Medical, Inc.
Model
g-Lix
Catalog number
301010
Device description
g-Lix Tissue Grabber
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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061268000G-LIX TISSUE GRASPERUsgi Medical2006-07-31HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009064741PackageGS13In Commercial Distribution
00860009064744PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000906474110860009064741
00860009064744008600090647448600090647440860009064744

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
00860009064720g-Prox EZ Endoscopic Grasperg-Prox EZ-162082002022-12-20
00860009064737g-Prox EZ Endoscopic Grasperg-Prox EZ-332082202022-12-20
00860009064751Transport Endoscopic Access DeviceTransport-R5001002022-12-20

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Primary DI, Brand, Company table
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