FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780085683
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
3734042
Catalog number
3734042
Device description
INSTRUMENT 3734042 7MM DISS/11MM RETRACT
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
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780085683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008568310381780085683

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00192896122888DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122895Ball DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122901Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122918Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122925Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122932Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
09348811151254INKAThe Trustee for KAISER FAMILY TRUSTGDI2026-03-16
00192896122703Ochsner DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-10
00840180544778General InstrumentsALPHATEC SPINE, INC.GDI2026-01-29
00840180544525General InstrumentsALPHATEC SPINE, INC.GDI2025-12-31
08809407604543DissectorHankil Tech Medical Co., Ltd.GDI2025-12-16
00196449034536Anatomic Access LLIFTyber Medical, LLCGDI2025-12-02
09348811025494INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811025500INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811146663INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
03662663276849Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-17
00757770701209Bausch + LombBausch & Lomb IncorporatedGDI2025-11-16
03662663267236Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267243Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267250Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
00757770676354Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
00757770688517Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
03662663131308Disc Preparation InstrumentsHighridge Medical, LLCGDI2025-11-14
03662663192835Breckenridge ACDF SystemHighridge Medical, LLCGDI2025-11-14
00196449034529Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00763000936440NAMEDTRONIC, INC.GDI2025-09-29
00192896122116Ball ProbeSONTEC INSTRUMENTS, INC.GDI2025-09-26
16971503601937comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
16971503601944comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28