FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403104732
Brand
V. Mueller
Company
STERIS CORPORATION
Model
OS4360-007
Catalog number
OS4360007
Device description
HIBBS GOUGE STRAIGHT BLADE 1 inches2.5CM WIDE OVERALL LENGTH 9-1/2 inches24.1CM
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
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403104732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540310473210885403104732

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be 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
09348811107954INKAThe Trustee for KAISER FAMILY TRUSTGDH2025-11-25
04026575033522Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033539Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033546Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033553Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033560Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
04026575033577Instruments for Revision SurgeryWALDEMAR LINK GmbH & Co. KGGDH2025-11-24
00190776408237MillenniumAvalign Technologies, Inc.GDH2025-08-07
00194613058371MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
00194613058395MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
00194613058678MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
04052536081066uCentumUlrich GmbH & Co. KGGDH2025-07-29
04052536081073uCentumUlrich GmbH & Co. KGGDH2025-07-29
04052536081080uCentumUlrich GmbH & Co. KGGDH2025-07-29
00840343726225GEN2SURGIX MEDICAL LLCGDH2025-05-08
00190776393199MillenniumAvalign Technologies, Inc.GDH2025-05-05
M9307591425310Life Instruments Life Instrument CorporationGDH2025-02-04
M9307591430310Life Instruments Life Instrument CorporationGDH2025-02-04
00190776390600MillenniumAvalign Technologies, Inc.GDH2024-11-19
00190776390617MillenniumAvalign Technologies, Inc.GDH2024-11-19
00190776387419MillenniumAvalign Technologies, Inc.GDH2024-11-08
00194613061043MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613061128MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613061869MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613062088MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613062095MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089184MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089191MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089207MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15
00194613089399MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2024-08-15