FDA.reportPublic FDA data

VorOtek Speculums

Primary DI
09348227002164
Brand
VorOtek Speculums
Company
VOROTEK PTY LTD
Model
VPS-B50-L
Catalog number
VPS-B50-L
Device description
VorOtek Speculums - Large. Pack of 50 Large Speculums. Autoclavable plastic
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348227002164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348227002164093482270021649348227002164

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744332997
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348227002171VorOtek SpeculumsVPS-B50-MVPS-B50-M2023-09-08
09348227002188VorOtek SpeculumsVPS-B50-SVPS-B50-S2023-09-08
09348227002195VorOtek SpeculumsVPS-B50-XLVPS-B50-XL2023-09-08
09348227002201VorOtek SpeculumsVPS-B50-XSVPS-B50-XS2023-09-08
09348227000016VorOtek O ScopeVSOS-2DVSOS-2D2023-08-09
09348227000023VorOtek O ScopeVSOH-2DVSOH-2D2023-08-09
09348227000092VorOtek L ScopeVSLH-2.5 LVSLH-2.5 L2023-08-09
09348227000108VorOtek L ScopeVSLH-2.5 MVSLH-2.5 M2023-08-09
09348227000160VorOtek M ScopeVSMSVSMS2023-08-09
09348227001181VorOtek X-Series HeadlightVLHH-DAVLHH-DA2023-08-09
09348227001938VorOtek O ScopeVSOH-3DVSOH-3D2023-08-09
09348227002089VorOtek O ScopeVSOS-3DVSOS-3D2023-08-09
09348227000153VorOtek M ScopeVSMHVSMH2023-08-08
09348227000290VorOtek LED HeadLightVLHH-DVLHH-D2023-08-08
09348227000139VorOtek L ScopeVSLS-2.5 MVSLS-2.5 M2023-07-24
09348227000122VorOtek L ScopeVSLS-2.5 LVSLS-2.5 L2023-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811148858INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148889INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148957INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148919INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
09348811148933INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
G043714000BEARBear-Ent, LLCEPY2026-05-07
G04371401G0GEIZBear-Ent, LLCEPY2026-05-07
G04371402G0GEIZBear-Ent, LLCEPY2026-05-07
G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
G043608500BEARBear-Ent, LLCEPY2022-05-23
10381780503453Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503460Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780503545Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2020-10-01
10381780478591Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-18
10381780506300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-09-12
10381780403852Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780418993Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419006Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16