FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780107934
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCO214-13-40
Catalog number
MCO214-13-40
Device description
MicroFrance® Fleury gouge, 4 mm, 130 mm length
Published
2018-01-12
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
KAQGOUGE, NASAL, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAQGouge, Nasal, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780107934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010793410381780107934

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
276593071
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780089032MicroFrance®7771B7771B2017-09-01
10381780099475Integra® MicroFrance®CP391CP3912016-09-20
10381780099482Integra® MicroFrance®CP391-3CP391-32016-09-20
10381780099499Integra® MicroFrance®CP391-4CP391-42016-09-20
10381780099505Integra® MicroFrance®CP391ECP391E2016-09-20
10381780099512Integra® MicroFrance®CP391MCP391M2016-09-20
10381780099529Integra® MicroFrance®CP391VCP391V2016-09-20
10381780099635Integra® MicroFrance®CP393CP3932016-09-20
10381780099642Integra® MicroFrance®CP393-2CP393-22016-09-20
10381780099659Integra® MicroFrance®CP393-3CP393-32016-09-20
10381780099666Integra® MicroFrance®CP393-4CP393-42016-09-20
10381780106104MicroFrance®MCL75MCL752018-01-10
10381780097327Integra® MicroFrance®CEV9649X5CEV9649X52016-09-20
10381780097433Integra® MicroFrance®CEV980BCEV980B2016-09-20
10381780092438Integra® MicroFrance®CEV204G45CEV204G452016-09-20
10381780094579Integra® MicroFrance®CEV627ICEV627I2016-09-20
10381780094869Integra® MicroFrance®CEV649-10BCEV649-10B2016-09-20
10381780094920Integra® MicroFrance®CEV649G5CEV649G52016-09-20
10381780095040Integra® MicroFrance®CEV658-10CEV658-102016-09-20
10381780095460Integra® MicroFrance®CEV81CEV812016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192896123007Alexander Mastoid GougeSONTEC INSTRUMENTS, INC.KAQ2026-03-31
00757770498956Bausch + LombBausch & Lomb IncorporatedKAQ2025-08-01
00190776392642MillenniumAvalign Technologies, Inc.KAQ2025-05-02
G586E3871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871840Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871850Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3871860Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E3873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7412490Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E7766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93871760Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873730Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873740Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873750Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E93873770Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97412240Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
G586E97766960Novo SurgicalNOVO SURGICAL, INC.KAQ2023-12-18
00842962147665HNM MEDICALHNM STAINLESS, LLC.KAQ2023-04-07
00190776362232MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362249MillenniumAvalign Technologies, Inc.KAQ2023-02-22
00190776362256MillenniumAvalign Technologies, Inc.KAQ2023-02-22
M6335143910JEDMEDJEDMED INSTRUMENT COMPANYKAQ2023-02-03
00190776295189MillenniumAvalign Technologies, Inc.KAQ2022-12-12
00190776295196MillenniumAvalign Technologies, Inc.KAQ2022-12-12