FDA.reportPublic FDA data

N/A

Primary DI
00841036157692
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
07-0088
Catalog number
07-0088
Published
2018-08-17
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
JYGCURETTE, EAR

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036157692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036157692008410361576928410361576920841036157692

GMDN Terms#

Term, Definition table
TermDefinition
Endaural curette, reusableA slender, hand-held, manual surgical instrument designed for scraping within the ear canal (e.g., removing wax), and during middle ear surgery (e.g., removal of the superior bony rim). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically 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(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
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
false
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
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00888233016902N/ASP-2482SP-24822020-06-16
008882330182272.0MM SYSTEMSP-2640SP-26402020-06-16
00888233078986VENAPAX XLVPX40002025-03-31
00888233012430N/ASP-1634SP-16342020-06-16
00888233013680CMF SYSTEMSP-1883SP-18832020-06-16
00888233013703CMF SYSTEMSP-1884SP-18842020-06-16
00888233013727CMF SYSTEMSP-1885SP-18852020-06-16
00888233013741CMF SYSTEMSP-1886SP-18862020-06-16
00888233025348LactoSorb SystemSP-1688SP-16882020-06-16
00888233025355LactoSorb SystemSP-1689SP-16892020-06-16
00888233025362LactoSorb SystemSP-1690SP-16902020-06-16
00888233025379LactoSorb System - MandibularSP-1778SP-17782020-06-16
00888233025386LactoSorb System - MandibularSP-1779SP-17792020-06-16
00888233025645LactoSorb System - MandibularSP-1944SP-19442020-06-16
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776418069MillenniumAvalign Technologies, Inc.JYG2026-03-23
00192896111783Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111790Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111806Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111813Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111820Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00192896111837Buck Ear CuretteSONTEC INSTRUMENTS, INC.JYG2026-02-26
00190776416478MillenniumAvalign Technologies, Inc.JYG2026-02-16
00190776416485MillenniumAvalign Technologies, Inc.JYG2026-02-16
00757770672080Bausch + LombBausch & Lomb IncorporatedJYG2025-12-12
04250676716422Buck ear curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-25
04250381855461Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855478Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855973Spoon curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855980Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381855997Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856000Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856017Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856024Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856031Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856086Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856093Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856109Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381856116Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863329Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863336Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863343Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381863350Spoon curette, semi-sharpSpiggle & Theis Medizintechnik GmbHJYG2025-09-19
04250381862490Tisch micro curetteSpiggle & Theis Medizintechnik GmbHJYG2025-09-11
00190776409357MillenniumAvalign Technologies, Inc.JYG2025-08-25