FDA.reportPublic FDA data

INKA

Primary DI
09348811150448
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
31246.16 RD
Catalog number
31246.16 RD
Device description
Micro Probe straight dull point-round handle
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAKProbe, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811150448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811150448093488111504489348811150448

GMDN Terms#

Term, Definition table
TermDefinition
General surgery wound probe/packerA slender, double-ended, hand-held manual surgical instrument intended to be used to explore and examine wounds, and additionally to introduce and pack gauze or dressings into the wound. It consists of a flat blunt blade at one end and a packer at the other end, with the handle formed from its middle section; it is made of metallic and/or synthetic polymer material. This is a single-use 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
09348811101655INKA30522.192026-04-24
09348811102522INKA36239.212026-04-24
09348811103796INKA33945.022026-04-24
09348811104236INKA31559.092026-04-24
09348811104595INKA31572.09 BL2026-04-24
09348811104908INKA33261.252026-04-24
09348811104915INKA33261.302026-04-24
09348811104953INKA33264.252026-04-24
09348811105653INKA33244.302026-04-24
09348811105707INKA33245.302026-04-24
09348811109408INKA31405.352026-04-24
09348811109415INKA31405.402026-04-24
09348811111975INKA31252.202026-04-24
09348811114891INKA31683.09 BL2026-04-24
09348811115829INKA33866.212026-04-24
09348811116673INKA33125.022026-04-24
09348811172099INKA31576.062026-04-24
09348811099037INKA31367.062026-04-10
09348811150233INKA31286.26 RD2026-04-10
09348811003119INKA10415.182026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811115829INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-04-24
09348811005106INKAThe Trustee for KAISER FAMILY TRUSTKAK2026-03-18
00714646001535Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
10714646001532Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
00714646001627Lighted Magnetic Foreign Body Removal ToolBionix, LLCKAK2026-03-03
09348811115836INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-25
09348811112149INKAThe Trustee for KAISER FAMILY TRUSTKAK2025-11-21
04250676728609Tube probeSpiggle & Theis Medizintechnik GmbHKAK2025-10-10
04250676731982Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676731999Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732002Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732026Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676732033Salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740625Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740632Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740649Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740656Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740663Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740687Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740694Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740700Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
04250676740717Bowman salivary duct probeSpiggle & Theis Medizintechnik GmbHKAK2025-09-29
00190776409487MillenniumAvalign Technologies, Inc.KAK2025-09-02
00757770407972Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00757770636334Bausch + LombBausch & Lomb IncorporatedKAK2025-08-05
00194613044404MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613048952MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613059804MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613102227MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01
00194613106287MSI Precision Specialty InstrumentsMed Saver, Inc.KAK2025-08-01