FDA.reportPublic FDA data

INKA

Primary DI
09348811172174
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
21914.01
Catalog number
21914.01
Device description
KERRISON Hygienic semi-detachable Bone Punch standard footplate 90° up-cutting 1mm bite 200mm shaft length without ejector
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811172174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811172174093488111721749348811172174

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
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
09348811150318INKA31252.04 RD2026-05-29
09348811150325INKA31252.06 RD2026-05-29
09348811150349INKA31252.10 RD2026-05-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
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