FDA.reportPublic FDA data

INKA

Primary DI
09348811149886
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
31266.06
Catalog number
31266.06
Device description
FISCH Micro Footplate Hook oval blunt ø 0.6mm 90° angled 16cm
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JYLHook, Microsurgical Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811149886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811149886093488111498869348811149886

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. 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
09348811083098INKA20706.182026-07-31
09348811100542INKA30258.002026-07-31
09348811102645INKA31351.172026-07-31
09348811102669INKA31352.172026-07-31
09348811103291INKA36429.052026-07-31
09348811109194INKA31278.162026-07-31
09348811111951INKA31252.122026-07-31
09348811111982INKA31255.042026-07-31
09348811112026INKA31255.152026-07-31
09348811114846INKA31657.132026-07-31
09348811150257INKA31287.20 RD2026-07-31
09348811155320INKA31255.032026-07-31
09348811155337INKA31255.122026-07-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462906680evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906697evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906703evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906710evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906727evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906734evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906765evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906772evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906796evonosevonos GmbH & Co. KGJYL2026-08-21
04054462906826evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907069evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907113evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907274evonosevonos GmbH & Co. KGJYL2026-08-21
04054462907335evonosevonos GmbH & Co. KGJYL2026-08-21
04054462911585evonosevonos GmbH & Co. KGJYL2026-08-19
04054462901524evonosevonos GmbH & Co. KGJYL2026-08-18
04054462901531evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906741evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906758evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906789evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906802evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906925evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906932evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906949evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906956evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906963evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906970evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906987evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906994evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907007evonosevonos GmbH & Co. KGJYL2026-08-18