FDA.reportPublic FDA data

Scope CleanOR

Primary DI
09349967002957
Brand
Scope CleanOR
Company
THE O R COMPANY PTY LTD
Model
SC-01
Published
2019-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967002940PackageGS125In Commercial Distribution
09349967002957PackageGS116In Commercial Distribution
09349967002933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967002940093499670029409349967002940
09349967002957093499670029579349967002957
09349967002933093499670029339349967002933

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning brush/tool, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744346235
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19349967004965Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26
19349967004972Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26
19349967004989Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-40NTUE-OBPRO-40NT2023-05-26
19349967005016Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-32NTUE-OBPRO-32NT2023-05-26
19349967005061Uterine ElevatOR PRO with Long Handle™UE-LHPRO-32NTUE-LHPRO-32NT2023-05-26
19349967005078Uterine ElevatOR PRO with Long Handle™UE-LHPRO-35NTUE-LHPRO-35NT2023-05-26
19349967005085Uterine ElevatOR PRO with Long Handle™UE-LHPRO-37NTUE-LHPRO-37NT2023-05-26
19349967005092Uterine ElevatOR PRO with Long Handle™UE-LHPRO-40NTUE-LHPRO-40NT2023-05-26
19349967005108Uterine PositionOR PRO™UE-PLH-NTUE-PLH-NT2023-05-26
29349967004993ColpotomizOR Tube SystemCTS35-TV2023-04-04
29349967005006ColpotomizOR Tube SystemCTS45-TV2023-04-04
09349967000724LapPakORW-18W-182018-06-23
09349967001448ColpotomizOR Tube35mmC35-TV2017-11-16
09349967001479ColpotomizOR Tube45mmC45-TV2017-11-16
09349967002261Uterine ElevatOR ProUE-TVPRO-322017-07-19
09349967002292Uterine ElevatOR ProUE-TVPRO-352017-07-19
09349967002322Uterine ElevatOR ProUE-TVPRO-372017-07-19
09349967002353Uterine ElevatOR ProUE-TVPRO-402017-07-19
09349967002773Uterine ElevatOR ProUE-TVPRO-322018-01-31
09349967002803Uterine ElevatOR ProUE-TVPRO-352018-01-31

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