FDA.reportPublic FDA data

KMEDIC

Primary DI
24026704287097
Brand
KMEDIC
Company
TELEFLEX INCORPORATED
Model
IPN015267
Catalog number
KM55630
Device description
GOUGE ENDOSCOPIC HIBBS 0.28" (7 MILLIMETER) STRAIGHT 18.5"
Published
2018-09-15
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

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
04026704287093Direct MarkingGS10
24026704287097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704287093040267042870934026704287093
2402670428709724026704287097

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length17Inch
Width1Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

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