FDA.reportPublic FDA data

AmplifEYE

Primary DI
00677964074196
Brand
AmplifEYE
Company
MEDIVATORS INC.
Model
EYE-101
Device description
AmplifEYE
Published
2018-02-13
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
FEDEndoscopic Access Overtube, Gastroenterology-Urology

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160846000AmplifEYEMedivators, Inc.2016-07-14FED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10677964074193PackageGS120Not in Commercial Distribution
20677964074190PackageGS1120Not in Commercial Distribution
00677964074196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067796407419310677964074193
2067796407419020677964074190
00677964074196006779640741966779640741960677964074196

GMDN Terms#

Term, Definition table
TermDefinition
Colonoscope distal anchoring cuffA device in the form of a cuff with concentric finger-like components intended to fit to a flexible colonoscope distal end to stabilize its tip within the colonic lumen and straighten the colonic folds to facilitate observation and/or surgical instrument use. The fingers are intended to open and grip the colon during pull back (exturbation); the device may in addition have a protruding distal end (spacer) intended to maintain distance between the endoscope tip and structures of interest. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags#

DUNS number
068199363
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964021695CER-1CER-178399-7232016-09-20
00677964033858DSD-201DSD-201 120VDSD20172016-09-20
00677964035647SSD-102SSD-102SSD20072016-09-20
00677964044755Advantage Plus Endoscope Reprocessing System1-2-510.0032016-09-16
00677964046674DSD Edge Endoscope Reprocessing SystemDSD Edge 120VDSD30082016-09-16
00677964052484CER-1 OptimaCER-1 OptimaCER1OPTIMA2016-09-20
00677964052491CER-2 OptimaCER-2 OptimaCER2OPTIMA2016-09-20
00677964095832Advantage Plus Pass-Thru1-2-610.003126100032018-02-06
00677964153877Endo Carry-on Procedure Kit401137340113732026-07-20
00677964153921Endo Carry-on Procedure Kit401139040113902026-07-20
00677964153976Endo Carry-on Procedure Kit401141240114122026-07-20
00677964154089Endo Carry-on Procedure Kit401144940114492026-07-20
00677964154096Endo Carry-on Procedure Kit401146040114602026-07-20
00677964051555Medivators HookupHookup58112CAS2024-04-01
00677964053450Medivators HookupHookup28338CAS2024-04-01
00677964002328Medivators HookupHookup28718CAS2023-04-10
00677964037856Medivators HookupHookup28612CAS2023-04-10
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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