FDA.reportPublic FDA data

JEDMED

Primary DI
M6333505680
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
35-0568
Catalog number
35-0568
Device description
NIPPER MALLEUS HOUSE-DIETERS
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JYRNipper, Malleus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYRNipper, MalleusEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6333505680PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear malleus nipperA hand-held manual surgical instrument intended to be used to cut the malleus (hammer-shaped lateral bone of the group of three that form the sound-transmitting ossicles in the middle ear). It is typically a ring-handled instrument with, distal to a pivot pin, a set of blades: one slides back and forth to operate a set of jaws for cutting, and the other is stationary and may end in a sharpened anvil or a hook. In the anvil design, the sliding blade opens and closes a second sharpened blade against the anvil. In the hook design, the sliding blade closes against the hook. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
092987189
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M63330170506L0JEDMED30-1705 06L30-1705 06L2020-09-01
M63330170506R0JEDMED30-1705 06R30-1705 06R2020-09-01
M63330170579H0JEDMED30-1705 79H30-1705 79H2020-09-01
M6333018340JEDMED30-183430-18342020-09-01
M6333018350JEDMED30-183530-18352020-09-01
M6333018360JEDMED30-183630-18362020-09-01
M6333103500JEDMED31-035031-03502020-09-01
M6333103510JEDMED31-035131-03512020-09-01
M6333104600JEDMED31-046031-04602020-09-01
M6333104750JEDMED31-047531-04752020-09-01
M63331047570JEDMED31-0475 731-0475 72020-09-01
M6333104760JEDMED31-047631-04762020-09-01
M63331047650JEDMED31-0476 531-0476 52020-09-01
M6333104770JEDMED31-047731-04772020-09-01
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088713602PRINCETONPrinceton Medical Group, Inc.JYR2026-08-25
00810158219731PRINCETONPrinceton Medical Group, Inc.JYR2026-04-22
00810158218970PRINCETONPrinceton Medical Group, Inc.JYR2026-03-11
00810158217713PRINCETONPrinceton Medical Group, Inc.JYR2025-10-17
00810158217874PRINCETONPrinceton Medical Group, Inc.JYR2025-10-17
00757770433650Bausch + LombBausch & Lomb IncorporatedJYR2025-08-05
00194613081287MSI Precision Specialty InstrumentsMed Saver, Inc.JYR2025-08-01
04049047779544GimmiGimmi GmbHJYR2025-05-27
00810158213524PRINCETONPrinceton Medical Group, Inc.JYR2024-11-18
00810158212602PRINCETONPrinceton Medical Group, Inc.JYR2024-07-24
00810158212640PRINCETONPrinceton Medical Group, Inc.JYR2024-07-24
00840183527464BR Surgical, LLCBR Surgical, LLCJYR2024-07-19
00840183526955BR Surgical, LLCBR Surgical, LLCJYR2024-05-29
00810158212190PRINCETONPrinceton Medical Group, Inc.JYR2024-05-14
00840306822612Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822629Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822636Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822643Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822650Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822667Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822674Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822681Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822698Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00840306822704Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYR2024-04-15
00810158211636PRINCETONPrinceton Medical Group, Inc.JYR2024-03-26
00810158210738PRINCETONPrinceton Medical Group, Inc.JYR2024-03-08
00842962144633HNM MedicalHNM STAINLESS, LLC.JYR2024-03-08
00810158210202PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
00810158210257PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
00810158210271PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06