FDA.reportPublic FDA data

OTOVIEW

Primary DI
00821925027206
Brand
OTOVIEW
Company
Gyrus ACMI, LLC
Model
REX23-5200
Device description
REPAIR EXCHANGE OTOVIEW SCOPE 1.7 MM 0 DEGREES
Published
2016-10-05
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
00821925027206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925027206008219250272068219250272060821925027206

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
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
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925019188OTOVIEWGyrus ACMI, LLCEWA2016-10-11
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
00821925027213OTOVIEWGyrus ACMI, LLCEWA2016-10-05
00821925027411OTOVIEWGyrus ACMI, LLCEWA2016-10-05