FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403009518
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
AU11360
Catalog number
AU11360
Device description
"LEMPERT MALLEUS CUTTER JAW LENGTH 11MM OVERALL LENGTH 4-1/2"" (11.4CM)"
Published
2018-07-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
10885403009518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540300951810885403009518

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403242342AchieveM1411M14112017-06-12
10885403242359AchieveM1415M14152017-06-12
10885403242366AchieveM1811M18112017-06-12
10885403242373AchieveM1815M18152017-06-12
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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