FDA.reportPublic FDA data

INKA

Primary DI
09348811172921
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
33353.25
Catalog number
33353.25
Device description
BACKBITER Rotating Antrum Punch with finger post rotation 360° cut 2.5mm shaft length 100mm -Luer lock cleaning channel
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
KBBRongeur, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811172921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811172921093488111729219348811172921

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. 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
04054462905768evonosevonos GmbH & Co. KGKBB2026-08-21
04054462910915evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910922evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910939evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910953evonosevonos GmbH & Co. KGKBB2026-08-19
04054462910960evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911011evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911028evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911035evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911042evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911059evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911066evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911073evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911080evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911097evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911103evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911110evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911127evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911134evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911141evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911158evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911165evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911172evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911189evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911196evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911202evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911219evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911226evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911233evonosevonos GmbH & Co. KGKBB2026-08-19
04054462911257evonosevonos GmbH & Co. KGKBB2026-08-19