FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403285561
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
OS4290-018
Catalog number
OS4290-018
Device description
"HIBBS BONE CHISEL CVD BLADE 1 1/8""-9 1/2"
Published
2018-12-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403285561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540328556110885403285561

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
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
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04058749075922NAFehling Instruments GmbH & Co. KGFZO2026-07-17
08800068960467BENCOXCorentec Co., LtdFZO2026-06-09
08806373887697BENCOX Surgical InstrumentsCorentec Co., LtdFZO2026-04-10
10649111080036Sklar®SKLAR CORPORATIONFZO2019-02-25
10649111010613Sklar®SKLAR CORPORATIONFZO2019-02-12
10649111052699Sklar®SKLAR CORPORATIONFZO2018-11-26
10381780495215Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780495314Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-24
10381780509325Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-23
10649111066283Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111066733Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067198Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067556Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111067938Sklar®SKLAR CORPORATIONFZO2018-10-22
10649111068317Sklar®SKLAR CORPORATIONFZO2018-10-22
10381780506874Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-10-17
10649111095245Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095443Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095559Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111095825Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096013Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096112Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096341Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096556Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096679Sklar®SKLAR CORPORATIONFZO2018-09-27
10649111096822Sklar®SKLAR CORPORATIONFZO2018-09-27
10603295084020SIGMADEPUY (IRELAND)FZO2018-09-24
10603295107798NADEPUY ORTHOPAEDICS, INC.FZO2018-09-24
10603295122715NADEPUY (IRELAND)FZO2018-09-24
10381780499176Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18