FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780107774
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCO205A
Catalog number
MCO205A
Device description
HOOK MCO205A 0.3MM 90DEG POSTERIOR
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
JYLHOOK, MICROSURGICAL EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780107774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010777410381780107774

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
10381780108337MicroFrance®MCO250MCO2502018-01-12
10381780110293MicroFrance®MCO820MCO8202018-01-12
10381780108351MicroFrance®MCO255MCO2552018-01-12
10381780111139MicroFrance®MCOP820MCOP8202018-01-12
10381780110286MicroFrance®MCO819MCO8192018-01-12
10381780100300MicroFrance®CP814-1CP814-12017-09-29
10381780100317MicroFrance®CP814-2CP814-22017-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04054462906734evonosevonos GmbH & Co. KGJYL2026-08-21
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04054462906772evonosevonos GmbH & Co. KGJYL2026-08-21
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04054462901524evonosevonos GmbH & Co. KGJYL2026-08-18
04054462901531evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906741evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906758evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906789evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906802evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906925evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906932evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906949evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906956evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906963evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906970evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906987evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906994evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907007evonosevonos GmbH & Co. KGJYL2026-08-18