FDA.reportPublic FDA data

INKA

Primary DI
09348811146717
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
25760.07
Catalog number
25760.07
Device description
RHOTON style Micro Spatula #7 medium, 19cm
Published
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXRSpatula, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXRSpatula, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811146717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811146717093488111467179348811146717

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811146700INKAThe Trustee for KAISER FAMILY TRUSTHXR2025-11-20
04059223157875REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223157899REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223157943REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223160837REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223160844REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223166273REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
04059223166280REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341216REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341230REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341278REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341223REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341247REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341254REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
14035282341261REMA Shaver BladesDEWIMED Medizintechnik GmbHHXR2025-02-26
D105SKU1312100SurgiMac Surgimac LLCHXR2024-04-22
00842517117280Karl SchumacherKarl Schumacher Dental, LLCHXR2024-03-15
00850047707260GillThe Radebaugh-Fetzer CompanyHXR2023-06-01
04026575341368LINK Instruments - Chisel, bone curette, raspatory, rongeurWALDEMAR LINK GmbH & Co. KGHXR2022-12-20
08800017284620LOSPA IS Spinal SystemCorentec Co., LtdHXR2022-10-20
00681490912235Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00681490912242Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXR2022-10-14
00840319718230Hayden MedicalHayden Medical, Inc.HXR2022-08-03
00840319701492Hayden MedicalHayden Medical, Inc.HXR2022-07-22
00840319701508Hayden MedicalHayden Medical, Inc.HXR2022-07-22
04251436928604KOHDENTKohler Medizintechnik GmbHHXR2021-09-22
04251436915178KOHDENTKohler Medizintechnik GmbHHXR2021-08-30
04251436921902KOHDENTKohler Medizintechnik GmbHHXR2021-08-30
04251436925115KOHDENTKohler Medizintechnik GmbHHXR2021-08-30
04251436925320KOHDENTKohler Medizintechnik GmbHHXR2021-08-30