FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780538530
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
7771
Catalog number
7771
Device description
MicroFrance® Albertini trocar for drain
Published
2024-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTETROCAR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTETrocar, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780089018PreviousGS10
10381780538530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008901810381780089018
1038178053853010381780538530

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, reusableA rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

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
276593071
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780089032MicroFrance®7771B7771B2017-09-01
10381780099475Integra® MicroFrance®CP391CP3912016-09-20
10381780099482Integra® MicroFrance®CP391-3CP391-32016-09-20
10381780099499Integra® MicroFrance®CP391-4CP391-42016-09-20
10381780099505Integra® MicroFrance®CP391ECP391E2016-09-20
10381780099512Integra® MicroFrance®CP391MCP391M2016-09-20
10381780099529Integra® MicroFrance®CP391VCP391V2016-09-20
10381780099635Integra® MicroFrance®CP393CP3932016-09-20
10381780099642Integra® MicroFrance®CP393-2CP393-22016-09-20
10381780099659Integra® MicroFrance®CP393-3CP393-32016-09-20
10381780099666Integra® MicroFrance®CP393-4CP393-42016-09-20
10381780106104MicroFrance®MCL75MCL752018-01-10
10381780097327Integra® MicroFrance®CEV9649X5CEV9649X52016-09-20
10381780097433Integra® MicroFrance®CEV980BCEV980B2016-09-20
10381780092438Integra® MicroFrance®CEV204G45CEV204G452016-09-20
10381780094579Integra® MicroFrance®CEV627ICEV627I2016-09-20
10381780094869Integra® MicroFrance®CEV649-10BCEV649-10B2016-09-20
10381780094920Integra® MicroFrance®CEV649G5CEV649G52016-09-20
10381780095040Integra® MicroFrance®CEV658-10CEV658-102016-09-20
10381780095460Integra® MicroFrance®CEV81CEV812016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055445930615SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930622SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930639SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930646SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930653SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
05055445930660SurtexSURTEX INSTRUMENTS LTD.KTE2026-05-12
04046826472153MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKTE2025-12-17
04250381812860Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-10-05
04250381812846Antrum trocar, beakedSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812853Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
04250381812877Antrum trocar, oblique beakSpiggle & Theis Medizintechnik GmbHKTE2025-09-10
00757770422029Bausch + LombBausch & Lomb IncorporatedKTE2024-11-21
00887482053300Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KTE2024-08-15
10381780540120MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
00381780105872MicroFrance®INTEGRA MICROFRANCEKTE2024-05-29
14026704912053PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
24026704912050PILLINGTELEFLEX INCORPORATEDKTE2024-05-24
00888515242265BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515242272BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243262BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
00888515243279BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KTE2024-02-28
G586E1063390Novo SurgicalNOVO SURGICAL, INC.KTE2023-12-18
07899893232154NEONAILNeoortho Produtos Ortopédicos S/A.KTE2023-11-29
00190776378455MillenniumAvalign Technologies, Inc.KTE2023-11-13
00190776322687MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
00190776375201MILLENNIUMAvalign Technologies, Inc.KTE2023-09-28
14026704809278PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
54026704809276PILLINGTELEFLEX INCORPORATEDKTE2022-12-08
00842331163500Novo Surgical Inc. NOVO SURGICAL, INC.KTE2022-11-13
14026704730886PILLINGTELEFLEX INCORPORATEDKTE2022-04-27