FDA.report

MicroFrance®

Primary DI
10381780111092
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCOP366A
Catalog number
MCOP366A
Device description
MicroFrance® Suction tube 90° angled 6 mm with finger control, rotatable connexion 1.2 mm diameter 190 mm WL70 mm
Published
2018-01-12
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
JZFTUBE, EAR SUCTION

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780111092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178011109210381780111092

GMDN Terms

TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10381780093558Integra® MicroFrance®CEV504A2016-09-21
10381780093565Integra® MicroFrance®CEV504B2016-09-21
10381780259367MicroFrance®CEV405UCEV405U2019-02-20
10381780259435MicroFrance®CEV531T3UCEV531T3U2019-02-20
10381780259503MicroFrance®CEV649B5UCEV649B5U2019-02-20
10381780259510MicroFrance®CEV649BGPUCEV649BGPU2019-02-20
10381780259572MicroFrance®CEV728BR5UCEV728BR5U2019-02-20
10381780259619MicroFrance®CEV8649B5UCEV8649B5U2019-02-20
10381780259626MicroFrance®CEV8649BGPUCEV8649BGPU2019-02-20
10381780259664MicroFrance®CEV891MUCEV891MU2019-02-20
10381780259695MicroFrance®CEV894MUCEV894MU2019-02-20
10381780259718MicroFrance®CEV895MUCEV895MU2019-02-20
10381780259794MicroFrance®CEV9649B5UCEV9649B5U2019-02-20
10381780259800MicroFrance®CEV9649BGPUCEV9649BGPU2019-02-20
10381780259879MicroFrance®CM107UCM107U2019-02-20
10381780259886MicroFrance®CM110UCM110U2019-02-20
10381780259893MicroFrance®CM111UCM111U2019-02-20
10381780259909MicroFrance®CM112UCM112U2019-02-20
10381780259916MicroFrance®CM113UCM113U2019-02-20
10381780259923MicroFrance®CM115UCM115U2019-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00757770428588Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770676491Bausch + LombBausch & Lomb IncorporatedJZF2026-02-11
00757770425044Bausch + LombBausch & Lomb IncorporatedJZF2026-02-04
00757770446629Bausch + LombBausch & Lomb IncorporatedJZF2025-12-12
09348811000743INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-12-02
00757770701230Bausch + LombBausch & Lomb IncorporatedJZF2025-11-16
00757770436842Bausch + LombBausch & Lomb IncorporatedJZF2025-11-14
04250676745668Suction tube with windowSpiggle & Theis Medizintechnik GmbHJZF2025-09-19
00757770452682Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
00757770680498Bausch + LombBausch & Lomb IncorporatedJZF2025-09-12
04250676740533Saxby-IrrigatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-11
04250676722539Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722546Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722553Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722560Panetti sinus tympani suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722577Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722584Panetti atticus suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722591Panetti suction separatorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722607Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676722614Panetti ear drum suction dissectorSpiggle & Theis Medizintechnik GmbHJZF2025-09-08
04250676733153Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733160Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733177Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733184Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733191Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733207Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676733214Nijmegen suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738547Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676738554Suction tubeSpiggle & Theis Medizintechnik GmbHJZF2025-09-03
04250676742865Preyer dissector, sinus tympaniSpiggle & Theis Medizintechnik GmbHJZF2025-09-03