FDA.reportPublic FDA data

SlimLine

Primary DI
00821925001824
Brand
SlimLine
Company
Gyrus ACMI, LLC
Model
GY275L-P
Device description
SlimLine Continuous Flow Operative Hysteroscope Visual Master Kit 5.5 mm, 1.7 mm, 5 FR Channel
Published
2016-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
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
00821925001824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925001824008219250018248219250018240821925001824

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical hysteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055313NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONHIH2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONHIH2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23
07613327055498NASTRYKER CORPORATIONHIH2016-09-23
07613327055498NASTRYKER CORPORATIONFAS2016-09-23
07613327055542Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055542Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055573Rev360STRYKER CORPORATIONFAS2016-09-23
07613327055597Rev360STRYKER CORPORATIONHIH2016-09-23
07613327055597Rev360STRYKER CORPORATIONFAS2016-09-23
07613327053777NASTRYKER CORPORATIONFAS2016-09-23
07613327053777NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONHIH2016-09-23
07613327053784NASTRYKER CORPORATIONFAS2016-09-23
07613327053791NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONFAS2016-09-23
07613327053807NASTRYKER CORPORATIONHIH2016-09-23
07613327053814NASTRYKER CORPORATIONFAS2016-09-23
07613327053814NASTRYKER CORPORATIONHIH2016-09-23
07613327053821NASTRYKER CORPORATIONHIH2016-09-23
07613327053845NASTRYKER CORPORATIONHIH2016-09-23
07613327053852NASTRYKER CORPORATIONHIH2016-09-23
07613327053852NASTRYKER CORPORATIONFAS2016-09-23
07613327053869NASTRYKER CORPORATIONHIH2016-09-23
07613327053869NASTRYKER CORPORATIONFAS2016-09-23
07613327053876NASTRYKER CORPORATIONHIH2016-09-23