FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780104230
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
MCEN96
Catalog number
MCEN96
Device description
MicroFrance® Fenestrated cup forceps, right, curved up 45 degree
Published
2018-01-10
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
KAEFORCEPS, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780104230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010423010381780104230

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
09348811103338INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-16
09348811103321INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-09
24026704934472PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934489PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934502PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934519PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934526PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934533PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934540PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934557PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934571PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934588PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934625PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934632PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
00810123209842Adler Instrument CompanyAdler, Inc.KAE2026-03-03
00190776417413MillenniumAvalign Technologies, Inc.KAE2026-02-27
00190776417468MillenniumAvalign Technologies, Inc.KAE2026-02-27
00848657078214AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
00848657078221AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
09008737448905SoftGrip Forceps 2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
09008737448912SoftGrip Forceps SR2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
G04362076B0BEARBear-Ent, LLCKAE2026-02-03
09348811103659INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
09348811103673INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
04046826104276Medicon ForcepsMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2025-12-15
09348811105424INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811129017INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811104199INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104229INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104328INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01