FDA.reportPublic FDA data

Integra® MicroFrance®

Primary DI
10381780490418
Brand
Integra® MicroFrance®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
MCEN320LP
Catalog number
MCEN320LP
Device description
LOANER Stamm Skull Base Instrument Kit
Published
2018-09-14
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
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY
GEIElectrosurgical, cutting & coagulation & accessories
JZFTUBE, EAR SUCTION
KADELEVATOR, ENT
KAEFORCEPS, ENT
KAKPROBE, ENT
KBDSCISSORS, NASAL
MMOTRAY, SURGICAL, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
JZFTube, Ear SuctionEar, Nose, Throat1
KADElevator, EntEar, Nose, Throat1
KAEForceps, EntEar, Nose, Throat1
KAKProbe, EntEar, Nose, Throat1
KBDScissors, NasalEar, Nose, Throat1
MMOTray, Surgical, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780490418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178049041810381780490418

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. 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
081277700
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

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