FDA.reportPublic FDA data

N/A

Primary DI
00850003396200
Brand
N/A
Company
Artelon
Model
61018
Catalog number
61018
Device description
Solid Pilot Tip Drill Bit Kit
Published
2023-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003396200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003396200008500033962008500033962000850003396200

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
(800) 610-3446tiffini.wittwer@artelon.com

Regulatory Flags#

DUNS number
066284070
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003396217FLEXBAND FIX51013510132023-05-24
00850003396248FlexBandTW012TW0122024-04-11
00850003396323FlexBandTW030TW0302024-04-11
00850003396187FlexBand Plus41068410682023-05-24
00850003396286FlexBand71004710042023-05-24
00850003396163FlexBand71016710162021-02-25
00850003396170FlexBand51004510042021-02-25
00868047000304FlexPatch31048310482019-12-23
00868047000311FlexPatch31050310502019-12-23
00868047000328FlexPatch31049310492019-12-23
00868047000335FlexBand31051310512019-12-23
00868047000342FlexBand31052310522019-12-23
00868047000359FlexBand31053310532019-12-23
00868047000366FlexBand31054310542019-12-23
00868047000373FlexBand31055310552019-12-23
00868047000380FlexBand31056310562019-12-23
00868047000397FlexBand31058310582019-12-23
00850003396033FlexBand Plus41057410572019-12-27
00850003396040FlexBand Plus41056410562019-12-27
00850003396057FlexBand Plus41055410552019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17
18257200076574CETRAOrthofix US LLCHTW2026-07-17
18257200131211Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131228Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131273Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200163823PILLAR SA TiOrthofix US LLCHTW2026-07-17
18257200163854PILLAR SA TiOrthofix US LLCHTW2026-07-17
07630008439866APTUSMedartis AGHTW2026-07-16
07630037811374APTUSMedartis AGHTW2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10