FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380082993
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH04-0002
Catalog number
CH04-0002
Device description
Cannulated Countersink 2.4mm Cannulated Screws
Published
2018-06-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWWCOUNTERSINK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380082993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538008299310885380082993

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008890247128986.5/8.0mm Countersink, Cannulated ZH QCZimmer, Inc.HWW2026-08-25
00841731153081ARTEMIS FUZEVILEX LLCHWW2026-07-22
00841731153098ARTEMIS FUZEVILEX LLCHWW2026-07-22
00196449017591A.L.P.S. mvX™Tyber Medical, LLCHWW2026-06-04
00196449017607A.L.P.S. mvX™Tyber Medical, LLCHWW2026-06-04
00196449017614A.L.P.S. mvX™Tyber Medical, LLCHWW2026-06-04
00841731146854TITANEX VILEX LLCHWW2026-05-15
00841731146878TITANEX VILEX LLCHWW2026-05-15
00841731146892TITANEX VILEX LLCHWW2026-05-15
00841731146915TITANEX VILEX LLCHWW2026-05-15
00841731146939TITANEX VILEX LLCHWW2026-05-15
03700569679170Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043990Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044003Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044010Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
08437019739430WasherCap™ Countersink 11 mmABANZA TECNOMED SL.HWW2026-03-30
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWW2026-03-30
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00841731135308Redemption VILEX LLCHWW2026-01-12
00840118126250Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00840118126267Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00889795141330Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.HWW2025-11-19
00194613014766MSI Precision Specialty InstrumentsMed Saver, Inc.HWW2025-08-01
00885556896464TRIGEN MAXSmith & Nephew, Inc.HWW2025-05-07