FDA.reportPublic FDA data

Integra® Miltex®

Primary DI
10381780420125
Brand
Integra® Miltex®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
19-481
Catalog number
19-481
Device description
"Integra® Miltex® House-Dieter Malleus Nipper, 3-1/4"" Shaft, 1.7mm Bite"
Published
2017-12-21
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
JYRNIPPER, MALLEUS

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780420125PrimaryGS10
H834194810SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178042012510381780420125

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

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
081277700
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
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

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Primary DI, Brand, Company table
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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
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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
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00842962144633HNM MedicalHNM STAINLESS, LLC.JYR2024-03-08
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00810158210257PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
00810158210271PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06