FDA.reportPublic FDA data

Zethon

Primary DI
05059358034989
Brand
Zethon
Company
ZETHON LIMITED
Model
S101461
Device description
STERILE IRRIGATION TUBE KIT - C SHANK
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233958000hekaDrillZethon, Ltd.2024-03-14ERL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15059358034986PackageGS15In Commercial Distribution
05059358034989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505935803498615059358034986
05059358034989050593580349895059358034989

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Regulatory Flags#

DUNS number
774901748
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05059358036136Zethon1035812025-10-22
05059358040492Zethon1040702025-10-22
05059358040508Zethon1040812025-10-22
05059358040515Zethon1040972025-10-22
05059358040799Zethon1041002025-10-22
05059358042397Zethon1041372025-10-22
05059358042403Zethon1041592025-10-22
05059358044605Zethon1033522025-10-22
05059358044643Zethon1041842025-10-22
05059358046807Zethon1040352025-10-22
05059358046814Zethon1040432025-10-22
05059358046821Zethon1040562025-10-22
05059358046838Zethon1040622025-10-22
05059358047026Zethon1043122025-10-22
05059358047033Zethon1043202025-10-22
05059358049259Zethon1034382025-10-22
05059358057575Zethon1044292025-10-22
05059358057582Zethon1044322025-10-22
05060528013345Zethon1033052025-10-22
05060528013352Zethon1033182025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816589021615Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
00816589021622Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAHBE2023-02-09
07630055505712PM2-A125Bien-Air Surgery SAHBE2023-02-09
07630055505729NANO MicromotorBien-Air Surgery SAHBE2023-02-09
07630055505750PM2-A70HDBien-Air Surgery SAHBE2023-02-09
07630055505767PM2-S70HDBien-Air Surgery SAHBE2023-02-09
07630055505774PM PERFOBien-Air Surgery SAHBE2023-02-09
07630055505798NANO CableBien-Air Surgery SAHBE2023-02-09
07613327504019NASTRYKER CORPORATIONHBE2021-07-08
07613327504057NASTRYKER CORPORATIONHBE2021-07-08
10887587057026NASynthes GmbHHBE2019-02-22
04546540246332NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246356NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246387NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246974NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540246981NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540251862NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356499NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356505NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356512NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356529NAStryker Leibinger GmbH & Co. KGHBE2016-08-24
04546540356536NAStryker Leibinger GmbH & Co. KGHBE2016-08-24