FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780109129
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCO38
Catalog number
MCO38
Device description
MicroFrance® Fenestrometer
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
JYJGAUGE, MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780109129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010912910381780109129

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. 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
09348811109439INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-05-29
14250368861062KURZ Meter incl. TrayHeinz Kurz GmbHJYJ2026-05-21
14250368862557Sizer OMEGA CONNECTORHeinz Kurz GmbHJYJ2026-05-21
14250368865404AC Sizer System PartialHeinz Kurz GmbHJYJ2026-05-21
14250368865503AC Sizer System TotalHeinz Kurz GmbHJYJ2026-05-21
09348811109408INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109415INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109446INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-03-18
09348811109422INKAThe Trustee for KAISER FAMILY TRUSTJYJ2025-12-01
00844505014700SKULL BASEGrace Medical, Inc.JYJ2025-09-26
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.JYJ2025-07-17
00844505014649NYTEBYTEGrace Medical, Inc.JYJ2025-07-02
00757770501274Bausch + LombBausch & Lomb IncorporatedJYJ2025-06-03
00194613116965MSI Precision Specialty InstrumentsMed Saver, Inc.JYJ2025-03-21
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolFreudenberg Medical, LLCJYJ2025-03-14
00840183527501BR Surgical, LLCBR Surgical, LLCJYJ2024-11-26
00887482114223Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-20
00887482113387Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-12
00190776378448MillenniumAvalign Technologies, Inc.JYJ2023-11-13
00844505014328BENSON UNIVERSAL IMPLANT SIZERGrace Medical, Inc.JYJ2023-09-27
00190776289232MillenniumAvalign Technologies, Inc.JYJ2023-06-23
00842331168475Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-13
00842331131288Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-10
04250381854891Castroviejo nasal caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16
04250676733726Joseph placing instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16
04250381848401Fisch reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848456Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848463Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848470Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381849453Reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13