FDA.reportPublic FDA data

Reveal

Primary DI
00816765012536
Brand
Reveal
Company
US Endoscopy
Model
00711771
Catalog number
00711771
Device description
The Reveal distal attachment cap is attached to the distal end of the endoscope to facilitate endoscopic therapy. The Reveal distal attachment cap is intended for the following: gastrointestinal mucosal resection (endoscopic mucosal resection) and keeping the suitable depth of endoscope's view field.
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCXendoscopic irrigation/suction system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765012533PackageGS110Not in Commercial Distribution
00816765012536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501253310816765012533
00816765012536008167650125368167650125360816765012536

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope tissue removal cap, single-useA plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
627879687
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
10724995184015Endo-Boot00711621007116212020-04-01
10724995184022Endo-Boot00711622007116222020-04-01
00724995190637ProArmor00711623007116232020-07-16
00724995190644ProArmor00711624007116242020-07-16
00724995180355NA3905133905132020-04-02
00724995180362CO2MPACT7103007103002020-04-02
00724995180386NA7103047103042020-04-02
00724995180409NA7104247104242020-04-02
00724995180416NA7104257104252020-04-02
00724995180423NA7104267104262020-04-02
00724995180430NA7106027106022020-04-02
00724995180447NA7106037106032020-04-02
00724995180454NA7106047106042020-04-02
00724995180522Torrent00711579007115792020-04-01
00724995180768UltramatrixUSBOLUSBOL2020-04-02
00724995180775UltramatrixUSBORUSBOR2020-04-02
00724995180782iSnare00711084007110842020-03-19
00724995180843Articulator00711804007118042020-04-01
00724995182472Short Throw00711018007110182020-03-19
00724995182489Short Throw00711019007110192020-03-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06936603212448Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212462Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212479Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
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08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
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00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
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00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
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