FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780078128
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
3714058
Catalog number
3714058
Device description
MicroFrance® Ballenger Chisel, 8 mm
Published
2017-06-02
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
KANCHISEL, NASAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780078128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007812810381780078128

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
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 FreerASPEN SURGICAL PRODUCTS, INC.KAN2024-08-15
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00888515236691BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KAN2024-02-28
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G586E7841480Novo SurgicalNOVO SURGICAL, INC.KAN2023-12-18