FDA.report

MicroFrance®

Primary DI
10381780107170
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCLS65
Catalog number
MCLS65
Device description
MicroFrance® Sataloff angled sickle knife 60 mm (pk3)
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
10381780107170PrimaryGS10
00381780107173Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178010717010381780107170
00381780107173003817801071733817801071730381780107173

GMDN Terms

TermDefinition
Laryngeal knifeA hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). 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
3
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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