FDA.report

MicroFrance®

Primary DI
10381780105459
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCL294
Catalog number
MCL294
Device description
MicroFrance® Abitbol light fiber for laryngoscope MCL290
Published
2018-01-10
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

Related Records

Contact Domains

Product Codes

CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780105459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178010545910381780105459

GMDN Terms

TermDefinition
ENT transilluminatorA hand-held instrument intended to be used to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination. It is connected through a light cable, that may or may not be part of the device, to a light source that generates the light. Its exterior is typically made of high-grade stainless steel; it has a fibreoptic bundle core that conducts the light to the target site. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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