FDA.reportPublic FDA data

Raw Surgical Corporation

Primary DI
G508KTS1010
Brand
Raw Surgical Corporation
Company
RAW SURGICAL CORPORATION
Model
Speculum
Catalog number
RSC-KTS1-01
Device description
Killian Speculum, Self Retaining Screw, 51x7mm
Published
2023-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
G508KTS1010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining ear speculumA hand-held manual instrument which typically comprises two arms joined at a pivot point and designed for expanding or stretching the tissue around the ear orifice when inserted and opened. It has a blunt distal tip and is used for examination or surgery, typically during ear/nose/throat (ENT) intervention. It is usually made of stainless steel with a self-retaining or adjustable mechanism and is available in various sizes, shapes and contours. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3055426189andy@doralcommercialinvestments.com

Regulatory Flags#

DUNS number
850405913
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G508RSC01836180Raw Surgical CorporationGELPI RETRACTORRSC-01836182023-12-01
G508RSC08019170Raw Surgical CorporationScissorRSC-08019172023-12-01
G508RSC08020170Raw Surgical CorporationScissorRSC-08020172023-12-01
G508RSC08493450Raw Surgical CorporationScissorRSC-08493452023-12-01
G508RSC08901180Raw Surgical CorporationScissorRSC-08901182023-12-01
G508RSC09408380Raw Surgical CorporationKERRISON RONGEURRSC-09408382023-12-01
G508RSC10186120Raw Surgical CorporationFORCEPSRSC-10186122023-12-01
G508RSC10188120Raw Surgical CorporationFORCEPSRSC-10188122023-12-01
G508RSC10256150Raw Surgical CorporationFORCEPSRSC-10256152023-12-01
G508RSC10302180Raw Surgical CorporationFORCEPSRSC-10302182023-12-01
G508RSC10310180Raw Surgical CorporationFORCEPSRSC-10310182023-12-01
G508RSC11153560Raw Surgical CorporationTEARDROP SUCTION TUBERSC-11153562023-12-01
G508RSC11239740Raw Surgical CorporationFORCEPSRSC-11239742023-12-01
G508RSC11281360Raw Surgical CorporationScissorRSC-11281362023-12-01
G508RSC11308160Raw Surgical CorporationFORCEPSRSC-11308162023-12-01
G508RSC11308200Raw Surgical CorporationFORCEPSRSC-11308202023-12-01
G508RSC11331210Raw Surgical CorporationSpinal ElevatorRSC-11331212023-12-01
G508RSC12250140Raw Surgical CorporationFORCEPSRSC-12250142023-12-01
G508RSC12251140Raw Surgical CorporationFORCEPSRSC-12251142023-12-01
G508RSC12350190Raw Surgical CorporationFORCEPSRSC-12350192023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10381780506317Integra® 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
10381780419228Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419235Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419280Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16
10381780419297Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16