Avalign

Primary DI
00190776043636
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM101-3296
Device description
House Dieters Malleus Nipper
Published
2021-11-03
Public version status
New
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
JYRNIPPER, MALLEUS

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776043636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776043636001907760436361907760436360190776043636

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(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
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
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158218970PRINCETONPrinceton Medical Group, Inc.JYR2026-03-11
00757770433650Bausch + LombBausch & Lomb IncorporatedJYR2025-08-05
00194613081287MSI Precision Specialty InstrumentsMed Saver, Inc.JYR2025-08-01
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
00810158210400PRINCETONPrinceton Medical Group, Inc.JYR2024-03-06
G586E7212680Novo SurgicalNOVO SURGICAL, INC.JYR2023-12-18
G586E7218110Novo SurgicalNOVO SURGICAL, INC.JYR2023-12-18
00190776221119AvalignAvalign Technologies, Inc.JYR2023-09-28
00190776318505MILLENNIUMAvalign Technologies, Inc.JYR2023-09-28