SlimLine

Primary DI
00821925002562
Brand
SlimLine
Company
Gyrus ACMI, LLC
Model
GYS-5
Device description
Semi-Rigid Scissors 5 Fr, (1.67mm), 42 CM
Published
2024-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890328000ADULT RESECTOSCOPECircon Video1990-02-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925002562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925002562008219250025628219250025620821925002562

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic scissors, reusableA hand-held flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

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