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

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
10381780541585CODMAN® ACCU-FLO®82620282-62022024-05-29
10381780541738CODMAN®82304882-30482024-05-29
10381780536918CODMAN® ACCU-FLO®82152082-15202024-05-29
10381780536925CODMAN® ACCU-FLO®82152182-15212024-05-29
10381780537373CODMAN®82409582-40952024-05-29
10381780537380CODMAN®82859182-85912024-05-29
10381780541578CODMAN® ACCU-FLO®82620182-62012024-05-29
10381780541745CODMAN®82304982-30492024-05-29
10381780090977Integra®961020096102002018-10-26
10381780075073Integra®165002516500252018-09-17
10381780075080Integra®165003016500302018-09-17
10381780075097Integra®165005016500502018-09-17
10381780518525CODMAN® HAKIM®82300782-30072020-06-02
10381780518532CODMAN® HAKIM®82300882-30082020-06-02
10381780518600CODMAN® HAKIM®82301582-30152020-06-02
10381780518716CODMAN® HAKIM®82302682-30262020-06-02
10381780518761CODMAN® HAKIM®82303582-30352020-06-02
10381780518808CODMAN® HAKIM®82303982-30392020-06-02
10381780518976CODMAN® HAKIM®82308282-30822020-06-02
10381780519010CODMAN® HAKIM®82308682-30862020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03830066950271GREEN IRFIskra Medical, d.o.o.GEI2026-11-02
00199150071999MedtronicMEDTRONIC NAVIGATION, INC.GEI2026-11-01
00810026184093Bipolar ForcepsSONIQUENCE, LLCGEI2026-11-01
00841019124147KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-31
00190776437299MillenniumAvalign Technologies, Inc.GDG2026-10-30
B382SD9206861090Surgical DirectSurgical Direct, Inc.KAE2026-10-30
B382SD9206861120Surgical DirectSurgical Direct, Inc.KAE2026-10-30
04953170467875THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
04953170467882THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-29
00841019124178KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-28
04250676751720ScissorsSpiggle & Theis Medizintechnik GmbHKBD2026-10-28
04250676751829Reynolds scissorsSpiggle & Theis Medizintechnik GmbHKBD2026-10-28
B382SD6200420Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD6200430Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62372600Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62372610Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62372620Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62372700Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62372710Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62372720Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62373320Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62373340Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD62373360Surgical DirectSurgical Direct, Inc.KAE2026-10-28
B382SD6787200Surgical DirectSurgical Direct, Inc.GDG2026-10-28
00724995328177V. MuellerSTERIS Deutschland GmbHKBD2026-10-27
00724995328184V. MuellerSTERIS Deutschland GmbHKBD2026-10-27
00724995328191V. MuellerSTERIS Deutschland GmbHKBD2026-10-27
00724995328207V. MuellerSTERIS Deutschland GmbHKBD2026-10-27
00724995328214V. MuellerSTERIS Deutschland GmbHKBD2026-10-27
00724995328245V. MuellerSTERIS Deutschland GmbHKBD2026-10-27