FDA.reportPublic FDA data

Oracle

Primary DI
10816765013448
Brand
Oracle
Company
US Endoscopy
Model
00711892
Catalog number
00711892
Device description
The Oracle EUS latex balloon- Olympus radial is used with Olympus radial endoscopes endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower gastrointestinal tract.
Published
2017-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163492000Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon LinearUnited States Endoscopy Group, Inc.2017-01-06FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765013448PackageGS120Not in Commercial Distribution
00816765013441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501344810816765013448
00816765013441008167650134418167650134410816765013441

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound endoscope balloon, Hevea-latexA sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
false
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973786293222Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
06973786293246Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
04547410566253FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410477245FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477276FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477306FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170423628GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170454356DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-13
04953170454271DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454288DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454295DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454301DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454325DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454349DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12