FDA.reportPublic FDA data

INKA

Primary DI
09348811117106
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
33136.55 FOL
Catalog number
33136.55 FOL
Device description
KILLIAN Septum Speculum sz:2 55mm 15cm -fiber optic light carrier
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FXFSpeculum, Illuminated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXFSpeculum, IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811117106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811117106093488111171069348811117106

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
742109993
Device count
1
Premarket exempt
true
Lot or batch
true
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
09348811022066INKA31654.082026-06-02
09348811105868INKA31740.082026-06-02
09348811111944INKA31252.102026-06-02
09348811115461INKA36187.132026-06-02
09348811148858INKA30149.052026-06-02
09348811148889INKA30149.082026-06-02
09348811148957INKA30124.502026-06-02
09348811100603INKA30260.002026-05-29
09348811100825INKA31210.012026-05-29
09348811100832INKA31210.022026-05-29
09348811105417INKA30445.252026-05-29
09348811109439INKA31405.502026-05-29
09348811114068INKA30727.172026-05-29
09348811114075INKA30728.172026-05-29
09348811148919INKA30124.302026-05-29
09348811148933INKA30124.402026-05-29
09348811150301INKA31243.16 RD2026-05-29
09348811150318INKA31252.04 RD2026-05-29
09348811150325INKA31252.06 RD2026-05-29
09348811150349INKA31252.10 RD2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604712429Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXF2022-10-28
00025715697550EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
20025715697554EZY DOSE KIDSAPOTHECARY PRODUCTS, LLCFXF2020-09-09
00050428387443CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXF2020-07-29
10050428387440CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXF2020-07-29
04987669101049DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31
04987669101070DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-31
04987669101018DIGITAL MEDICAL SCOPENIDEK CO.,LTD.FXF2017-01-27