FDA.report

MicroFrance®

Primary DI
10381780106432
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCL93
Catalog number
MCL93
Device description
KNIFE MCL93 220MM W/3 BLADES BOUCHAYER
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
JZYKNIFE, LARYNGEAL

Product Code Classifications

CodeDeviceSpecialtyClass
JZYKnife, LaryngealEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780106432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178010643210381780106432

GMDN Terms

TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). 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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10381780259916MicroFrance®CM113UCM113U2019-02-20
10381780259923MicroFrance®CM115UCM115U2019-02-20

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