FDA.reportPublic FDA data

Scope HelpOR Pro

Primary DI
09349967001547
Brand
Scope HelpOR Pro
Company
THE O R COMPANY PTY LTD
Model
SHKPRO-02
Published
2019-03-27
Public version status
Update
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
OCTAnti Fog Solution And Accessories, Endoscopy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCTAnti Fog Solution And Accessories, EndoscopyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967001554PackageGS120In Commercial Distribution
09349967001561PackageGS16In Commercial Distribution
09349967001547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967001554093499670015549349967001554
09349967001561093499670015619349967001561
09349967001547093499670015479349967001547

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Regulatory Flags#

DUNS number
744346235
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349967002759Uterine ElevatOR ProUE-TVPRO-322018-01-31
09349967002780Uterine ElevatOR ProUE-TVPRO-352018-01-31
09349967002810Uterine ElevatOR ProUE-TVPRO-372018-01-31
09349967002841Uterine ElevatOR Pro UE-TVPRO-402018-01-31
09349967003268Lap Scope WarmORSW-5-10-R2019-03-27
09349967003442ColpotomizOR Tube SystemCTS35-TV2019-03-27
09349967003473ColpotomizOR Tube SystemCTS45-TV2019-03-27
09349967004036Skin MarkOR Fine TipSMOR-F2021-04-12
09349967004067Skin MarkOR Regular TipSMOR-R2021-04-12
09349967004210Laparoscopic Smoke EvacuatorLSE-012021-04-12
09349967004968Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26
09349967004975Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26
09349967004982Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-40NTUE-OBPRO-40NT2023-05-26
09349967005019Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-32NTUE-OBPRO-32NT2023-05-26
09349967005064Uterine ElevatOR PRO with Long Handle™UE-LHPRO-32NTUE-LHPRO-32NT2023-05-26
09349967005071Uterine ElevatOR PRO with Long Handle™UE-LHPRO-35NTUE-LHPRO-35NT2023-05-26
09349967005088Uterine ElevatOR PRO with Long Handle™UE-LHPRO-37NTUE-LHPRO-37NT2023-05-26
09349967005095Uterine ElevatOR PRO with Long Handle™UE-LHPRO-40NTUE-LHPRO-40NT2023-05-26
09349967005101Uterine PositionOR PRO™UE-PLH-NTUE-PLH-NT2023-05-26
19349967004965Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
27290019426053Plasma ShieldPlasmatica Ltd.OCT2025-12-15
04714127863153blue endoUNIMAX MEDICAL SYSTEMS INC.OCT2024-06-20
14714127863150blue endoUNIMAX MEDICAL SYSTEMS INC.OCT2024-06-20
10195327105365Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OCT2023-10-29
40195327105366Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OCT2023-10-29
10080196693450MedlineMEDLINE INDUSTRIES, INC.OCT2023-10-13
40080196693451MedlineMEDLINE INDUSTRIES, INC.OCT2023-10-13
27290019426008Plasma ShieldPlasmatica Ltd.OCT2023-05-17
27290019426022Plasma ShieldPlasmatica Ltd.OCT2023-05-17
00840113200597Dr. Fog® Solution With SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200627Dr. Fog® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200863Aspen® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206896Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206926Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214105Leonhard Lang/Fannin Anti-Fog Kit; SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200580Dr. Fog® Solution With SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200603Dr. Fog® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113200870Aspen® Anti-fog SolutionASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206902Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113206957Dr. Fog® Treated SpongeASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214099Leonhard Lang/Fannin Anti-Fog Kit; SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113214822Medline Anti-Fog, SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
00840113230433ArcRoyal Anti-Fog, Regular Solution, SterileASPEN SURGICAL PRODUCTS, INC.OCT2021-02-25
04714127860893CONMEDUNIMAX MEDICAL SYSTEMS INC.OCT2019-12-17
20326053102626Regard™Resource Optimization & Innovation, L.L.C.OCT2019-10-30
10326053102629Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OCT2019-10-30
09349967002032AntiFogORTHE O R COMPANY PTY LTDOCT2019-09-25
09349967002056AntiFogORTHE O R COMPANY PTY LTDOCT2019-09-25
10885380166204CARDINAL HEALTHCardinal Health 200, LLCOCT2019-08-08
00849771037859Key Surgical Mr. Clear Anti-FogKEY SURGICAL, INC.OCT2019-07-24