FDA.report

MicroFrance®

Primary DI
10381780107958
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCO214-13-80
Catalog number
MCO214-13-80
Device description
MicroFrance® Fleury gouge, 8 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KAQGOUGE, NASAL, ENT

Product Code Classifications

CodeDeviceSpecialtyClass
KAQGouge, Nasal, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780107958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178010795810381780107958

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
276593071
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 DIBrandModelCatalogPublished
10381780093558Integra® MicroFrance®CEV504A2016-09-21
10381780093565Integra® MicroFrance®CEV504B2016-09-21
10381780259367MicroFrance®CEV405UCEV405U2019-02-20
10381780259435MicroFrance®CEV531T3UCEV531T3U2019-02-20
10381780259503MicroFrance®CEV649B5UCEV649B5U2019-02-20
10381780259510MicroFrance®CEV649BGPUCEV649BGPU2019-02-20
10381780259572MicroFrance®CEV728BR5UCEV728BR5U2019-02-20
10381780259619MicroFrance®CEV8649B5UCEV8649B5U2019-02-20
10381780259626MicroFrance®CEV8649BGPUCEV8649BGPU2019-02-20
10381780259664MicroFrance®CEV891MUCEV891MU2019-02-20
10381780259695MicroFrance®CEV894MUCEV894MU2019-02-20
10381780259718MicroFrance®CEV895MUCEV895MU2019-02-20
10381780259794MicroFrance®CEV9649B5UCEV9649B5U2019-02-20
10381780259800MicroFrance®CEV9649BGPUCEV9649BGPU2019-02-20
10381780259879MicroFrance®CM107UCM107U2019-02-20
10381780259886MicroFrance®CM110UCM110U2019-02-20
10381780259893MicroFrance®CM111UCM111U2019-02-20
10381780259909MicroFrance®CM112UCM112U2019-02-20
10381780259916MicroFrance®CM113UCM113U2019-02-20
10381780259923MicroFrance®CM115UCM115U2019-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00190776295202MillenniumAvalign Technologies, Inc.KAQ2022-12-12