FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780108351
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCO255
Catalog number
MCO255
Device description
MicroFrance® Teixido cartilage cutting block, 0.3mm size
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNRBLOCK, CUTTING, ENT, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNRBlock, Cutting, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780108351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010835110381780108351

GMDN Terms#

Term, Definition table
TermDefinition
ENT cartilage cutterA portable, manual surgical instrument intended to cut a harvested cartilage specimen (e.g., tragus-derived autograft) to an accurate predetermined thickness for patient implantation during an ear/nose/throat (ENT) procedure (e.g., middle ear surgery). It typically consists of an adjustable cutting assembly with a handle, base, and thickness dial used in conjunction with a removable ENT cartilage cutter blade. This is a reusable device intended to be sterilized prior to use.

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
04250676741882Cutting blockSpiggle & Theis Medizintechnik GmbHNNR2025-09-25
00190776407810MillenniumAvalign Technologies, Inc.NNR2025-08-01
00194613022167MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00194613030223MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00887482040379Symmetry SurgicalSYMMETRY SURGICAL INC.NNR2024-09-09
G043670000BEARBear-Ent, LLCNNR2024-08-15
00840183503512BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840183527396BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840306827525Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827532Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827549Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827556Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00190776293307MILLENNIUMAvalign Technologies, Inc.NNR2023-09-28
00190776320874MILLENNIUMAvalign Technologies, Inc.NNR2023-09-28
00840319753132Hayden MedicalHayden Medical, Inc.NNR2023-05-26
00842962145807HNM MEDICALHNM STAINLESS, LLC.NNR2023-04-03
54026704805698PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
14026704805683PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
00840306806865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00840306806889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00842331134210Novo Surgical Inc. NOVO SURGICAL, INC.NNR2022-11-10
00840306806872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-08
04250374712269Cutting block, glassSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250381850169Preparation tray, stainless steelSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250676732354Fisch cutting and preparation jigSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250676732361Fisch cutting and preparation jigSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250676735393Piston cutting jigSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
00840319705803Hayden MedicalHayden Medical, Inc.NNR2022-07-27
00190776045289AvalignAVALIGN TECHNOLOGIES, INC.NNR2021-11-03
00190776213459AvalignAVALIGN TECHNOLOGIES, INC.NNR2021-11-03