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
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

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