FDA.reportPublic FDA data

Olympus

Primary DI
05019778008687
Brand
Olympus
Company
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
Model
ARV140
Catalog number
K10037619
Published
2023-10-30
Public version status
New
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019778008684PrimaryGS10
05019778008687Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1501977800868415019778008684
05019778008687050197780086875019778008687

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope observation cap, single-useA short, light-penetrating tube designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap and is available in a range of diameters to accommodate common endoscope diameters. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217061423
Device count
8
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15019778008653OlympusARV110K100376162023-10-30
15019778008660OlympusARV120K100376172023-10-30
15019778008677OlympusARV130K100376182023-10-30
15019778008684OlympusARV140K100376192023-10-30
05019778008656OlympusARV110K100376162023-10-30
05019778008663OlympusARV120K100376172023-10-30
05019778008670OlympusARV130K100376182023-10-30
15019778000879OlympusEndosonic2016-09-19
15019778007700OlympusMAJ-2207K100350022023-07-18
15019778007717OlympusMAJ-2208K100350032023-07-18
15019778007724OlympusMAJ-2209K100350042023-07-18
15019778007731OlympusMAJ-2210K100350052023-07-18
15019778008516OlympusMAJ-2220K100371612023-07-18
15019778008523OlympusMAJ-2221K100371622023-07-18
15019778008530OlympusMAJ-2222K100371632023-07-18
15019778008547OlympusMAJ-2223K100371642023-07-18
15019778008646OlympusWide-Eye Polyp TrapK100376262023-07-18
15019778005072OlympusMAJ-1681K100266412023-07-05
15019778005089OlympusMAJ-1682K100266862023-07-05
15019778005225OlympusTC-E300 Energy Cart – ROWK100268092023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973356551738TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551745TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551752TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551769TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551776TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06973356551783TriousShenzhen Trious Medical Technology Co., LtdFED2026-06-23
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06925816667213ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667220ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFED2026-03-16
06970462547457Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547464Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547471Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547488Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547495Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547501Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547518Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547525Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547532Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547549Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10
06970462547556Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.FED2026-02-10