FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380086359
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH10-0019
Catalog number
CH10-0019
Device description
Sharp Hook
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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380086359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538008635910885380086359

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. 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
10884521022683Monoject85121851212016-09-24
10884521023437Monoject890689062019-07-19
30884521018444Monoject8990Y8990Y2017-01-06
40884521018298Monoject89671896712016-09-24
40884521018380Monoject8970Y8970Y2017-01-06
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132568Tools-AFSTrimed, INC.FZX2026-07-24
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
18257200131198Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131204Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131235Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131334Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200163625PILLAR SA TiOrthofix US LLCFZX2026-07-17
00190446972020Generic InstrumentTrilliant Surgical, LLCFZX2026-07-16
00190446972037Generic InstrumentTrilliant Surgical, LLCFZX2026-07-16
G079PDG2000Advantage-C Ti3D, Cervical InterbodyIntelivation, LLCFZX2026-07-10
M697X07901121Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FZX2026-07-08
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
09421038412244KA Femoral Alignment Guide - Medial PaddleENZTEC LIMITEDFZX2026-06-24
09421038412251KA Femoral Alignment Guide - Lateral PaddleENZTEC LIMITEDFZX2026-06-24