FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780111320
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCOS17
Catalog number
MCOS17
Device description
MicroFrance® Selesnick knife, 1 mm tip, 190 mm length
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYOKNIFE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780111320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011132010381780111320

GMDN Terms#

Term, Definition table
TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. 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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811150134INKAThe Trustee for KAISER FAMILY TRUSTJYO2026-03-16
00757770712281Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
00757770714056Bausch + LombBausch & Lomb IncorporatedJYO2026-02-11
09348811108906INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811149923INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150141INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150189INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811150196INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-12-02
09348811111746INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111753INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111760INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
09348811111777INKAThe Trustee for KAISER FAMILY TRUSTJYO2025-11-24
00757770676316Bausch + LombBausch & Lomb IncorporatedJYO2025-11-14
00844505014694SKULL BASEGrace Medical, Inc.JYO2025-09-26
00757770636235Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770668564Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770672103Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770682584Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770682591Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770683611Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770683628Bausch + LombBausch & Lomb IncorporatedJYO2025-08-13
00757770404001Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770405206Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770407590Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770407712Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770408634Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770409723Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770410767Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770413980Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05
00757770414963Bausch + LombBausch & Lomb IncorporatedJYO2025-08-05