FDA.report

MSI Precision Specialty Instruments

Primary DI
00194613094591
Brand
MSI Precision Specialty Instruments
Company
Med Saver, Inc.
Model
19016-0585-2015
Device description
Walter Type Gouge 15mm Wide Slightly Angled Forward With Overall Length Of 8" (20cm)
Published
2024-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00194613094591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00194613094591001946130945911946130945910194613094591

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)935-8181sales@msiprecision.com

Regulatory Flags

DUNS number
556623486
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00194613000004MSI Precision Specialty InstrumentsCA10002025-08-01
00194613000011MSI Precision Specialty InstrumentsCA10102025-08-01
00194613000028MSI Precision Specialty InstrumentsCA10202025-08-01
00194613000059MSI Precision Specialty InstrumentsCA10502025-08-01
00194613000080MSI Precision Specialty InstrumentsCA10702025-08-01
00194613000097MSI Precision Specialty InstrumentsCA10802025-08-01
00194613000264MSI Precision Specialty InstrumentsCA12PK-302025-08-01
00194613000332MSI Precision Specialty InstrumentsCA19102025-08-01
00194613000370MSI Precision Specialty InstrumentsCA19502025-08-01
00194613000394MSI Precision Specialty InstrumentsCA19702025-08-01
00194613000462MSI Precision Specialty InstrumentsCA20402025-08-01
00194613000509MSI Precision Specialty InstrumentsCA20802025-08-01
00194613000639MSI Precision Specialty InstrumentsCA22102025-08-01
00194613000707MSI Precision Specialty InstrumentsCA22802025-08-01
00194613000769MSI Precision Specialty InstrumentsCA23402025-08-01
00194613000806MSI Precision Specialty InstrumentsCA23702025-08-01
00194613000813MSI Precision Specialty InstrumentsCA23802025-08-01
00194613000912MSI Precision Specialty InstrumentsCA24702025-08-01
00194613000943MSI Precision Specialty InstrumentsCA25002025-08-01
00194613000950MSI Precision Specialty InstrumentsCA2500-1.5-902025-08-01

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Primary DIBrandCompanyProduct codePublished
09348811107954INKAThe Trustee for KAISER FAMILY TRUSTGDH2025-11-25
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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
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00194613058371MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
00194613058395MSI Precision Specialty InstrumentsMed Saver, Inc.GDH2025-08-01
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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
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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