FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403104039
Brand
V. Mueller
Company
STERIS CORPORATION
Model
OS4290-002
Catalog number
OS4290002
Device description
HIBBS BONE CHISEL STRAIGHT BLADE WIDTH 3/8 inches 9MM OVERALL LENGTH 9-1/2 inches 24.1CM
Published
2018-09-10
Public version status
Update
Distribution status
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
10885403104039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540310403910885403104039

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
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
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
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10381780499183Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18
10381780499190Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-18