FDA.reportPublic FDA data

INKA

Primary DI
09348811146069
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
33343.20
Device description
OSTRUM Terrier Antrum Punch backward cutting 2.0mm oval cut up-curved shaft length 110mm
Published
2026-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
09348811146069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811146069093488111460699348811146069

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
09348811022066INKA31654.082026-06-02
09348811105868INKA31740.082026-06-02
09348811111944INKA31252.102026-06-02
09348811115461INKA36187.132026-06-02
09348811148858INKA30149.052026-06-02

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