FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780078098
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
3714055
Catalog number
3714055
Device description
CHISEL 3714055 BALLENGER V EDGE 2MM
Published
2017-06-02
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KANCHISEL, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KANChisel, NasalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780078098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007809810381780078098

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
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810207783299Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAN2025-11-24
00810207783305Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAN2025-11-24
04250676731142ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731159ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731166ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731173ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731180ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731197ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676731517ChiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-28
04250676740540Cottle chiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-18
04250676740557Cottle chiselSpiggle & Theis Medizintechnik GmbHKAN2025-09-18
04049047120520GimmiGimmi GmbHKAN2025-05-21
04049047121251GimmiGimmi GmbHKAN2025-05-21
04049047387459GimmiGimmi GmbHKAN2025-05-21
00887482146286Symmetry Surgical®SYMMETRY SURGICAL INC.KAN2024-08-15
00888515236646BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236653BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236660BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236677BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236684BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
00888515236691BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
G586E3871130Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871140Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871150Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871160Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871170Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E3871190Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841400Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841450Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18
G586E7841480Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18