FDA.reportPublic FDA data

MicroFrance®

Primary DI
10381780089803
Brand
MicroFrance®
Company
INTEGRA MICROFRANCE
Model
7829-13
Catalog number
7829-13
Device description
CURETTE 7829-13 13MM LERMOYER
Published
2017-06-02
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
KBJCURETTE, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBJCurette, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780089803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178008980310381780089803

GMDN Terms#

Term, Definition table
TermDefinition
AdenotomeA hand-held manual surgical instrument designed to excise hypertrophic lymphoid tissue in the nasopharynx (i.e., pharyngeal tonsils or adenoids) during a procedure known as an adenoidectomy. It is typically a long, slender instrument with cutting blades at the working end, and a handle with a mechanism to operate the blades. It is available in various designs and sizes and may be a one-piece instrument or require the insertion of the blades into the handle. 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
00194613048723MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048730MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048747MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048754MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048778MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048792MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048808MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048822MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048839MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048846MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048877MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613057329MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613068820MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613124014MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
04049047340003GimmiGimmi GmbHKBJ2025-05-22
04049047340010GimmiGimmi GmbHKBJ2025-05-22
04049047340027GimmiGimmi GmbHKBJ2025-05-22
04049047340034GimmiGimmi GmbHKBJ2025-05-22
04049047371595GimmiGimmi GmbHKBJ2025-05-22
04049047371601GimmiGimmi GmbHKBJ2025-05-22
04049047385509GimmiGimmi GmbHKBJ2025-05-22
04049047385516GimmiGimmi GmbHKBJ2025-05-22
04049047387497GimmiGimmi GmbHKBJ2025-05-22
00194613048709MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048716MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048761MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048815MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048860MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00840183507268BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10
00840183512446BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10