FDA.reportPublic FDA data

OTOVIEW

Primary DI
00821925019188
Brand
OTOVIEW
Company
Gyrus ACMI, LLC
Model
23-5210
Device description
OTOVIEW RIGID ENDOSCOPE 2.4 MM, 0 DEGREES NONAUTOCLAVABLE
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EWASET, AUDIOMETER CALIBRATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWASet, Audiometer CalibrationEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934432000OTOVIEW ENDOSCOPY SYSTEMSmith & Nephew Richards, Inc.1994-04-25EWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925019188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925019188008219250191888219250191880821925019188

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, endoscopicAn endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034433Gyrus ACMI1315002016-10-07
00821925002104USA Elite SystemEOS-HCF272024-11-21
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002470SlimlineGYA-52024-07-24
00821925002494SlimLineGYB-52024-07-24
00821925002562SlimLineGYS-52024-07-24
00821925002579GYRUS ACMI, INCGYS-7422024-07-24
00821925004634Gyrus ACMI2442024-07-23
00821925001152URO-GUIDE54960162015-10-24
00821925001169URO-GUIDE54960202015-10-24
00821925001480USA EliteCLO-232016-10-13
00821925001497USA EliteCLS-232016-10-13
00821925001602Elite 2 SystemE2RIS-CF272016-10-13
00821925001626Elite 2 SystemE2ROS-CF272016-10-13
00821925001633Elite 2 SystemE2RST-CF252016-10-13
00821925001657Elite 2 SystemE2RTO-CF252016-10-13
00821925001664Elite 2 SystemE2RTO-CF272016-10-13
00821925001671Elite 2 SystemE2RVO-CF252016-10-13
00821925001688Elite 2 SystemE2RVO-CF272016-10-13
00821925001695Elite 2 SystemE2TO-CF252016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925019195OTOVIEWGyrus ACMI, LLCEWA2016-10-11
00821925019201OTOVIEW Gyrus ACMI, LLCEWA2016-10-11
00821925019379OTOVIEWGyrus ACMI, LLCEWA2016-10-11
00821925019386OTOVIEW Gyrus ACMI, LLCEWA2016-10-11
00821925027183OTOVIEWGyrus ACMI, LLCEWA2016-10-05
00821925027190OTOVIEWGyrus ACMI, LLCEWA2016-10-05
00821925027206OTOVIEWGyrus ACMI, LLCEWA2016-10-05
00821925027213OTOVIEWGyrus ACMI, LLCEWA2016-10-05
00821925027411OTOVIEWGyrus ACMI, LLCEWA2016-10-05