FDA.reportPublic FDA data

INKA

Primary DI
09348811103796
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
33945.02
Device description
Frontal Sinus Recess Giraffe Forceps double action cupped jaw 2x4mm cup 90° up vertical shaft length 130mm
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAEForceps, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811103796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811103796093488111037969348811103796

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
09348811109798INKA30370.192026-07-30
09348811149756INKA31254.062026-07-30
09348811146069INKA33343.202026-07-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9196141000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9196141010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421020Surgical DirectSurgical Direct, Inc.KAE2026-07-29
00190776405908MillenniumAvalign Technologies, Inc.KAE2026-07-26
00190776404147MillenniumAvalign Technologies, Inc.KAE2026-07-24
00190776403874MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403911MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403782MillenniumAvalign Technologies, Inc.KAE2026-07-21
04046826110833MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-07-21
00190776402198MillenniumAvalign Technologies, Inc.KAE2026-07-19
00190776395353MillenniumAvalign Technologies, Inc.KAE2026-07-14
00850083275785Intrace USAPILOTIS TECH LLCKAE2026-07-03
00850083275860Intrace USAPILOTIS TECH LLCKAE2026-07-03
04054462923465evonosevonos GmbH & Co. KGKAE2026-06-26
00810220800294Adler Instrument CompanyAdler, Inc.KAE2026-06-02
09348811022066INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-06-02
09348811105417INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-05-29
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12
09348811105400INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-21