FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780101239
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
CP978
Catalog number
CP978
Device description
RASP CP978 170MM STR
Published
2018-01-10
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
KBARASP, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBARasp, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780101239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178010123910381780101239

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at its working end(s) designed to scrape and smooth the surface of hard tissues (e.g., bone, cartilage) during plastic surgery (e.g., rhinoplasty, face lifting). It is typically a one-piece instrument which resembles a coarse or fine file, but with sharp cutting projections instead of lines and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
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
00810220800256Adler Instrument CompanyAdler, Inc.KBA2026-05-26
00190776420147MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420154MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420161MillenniumAvalign Technologies, Inc.KBA2026-04-16
14026704941688PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
24026704941685PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
09348811102744INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103246INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103253INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103260INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
G043662100BEARBear-Ent, LLCKBA2025-10-08
04250676732187Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676732194Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676740229Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
04250676740236Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
00190776409920MillenniumAvalign Technologies, Inc.KBA2025-09-08
00194613032586MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
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00194613032685MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613047887MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110314MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110321MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613111236MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613116941MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613117115MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613117849MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613119737MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01