FDA.reportPublic FDA data

Avalign

Primary DI
00190776043841
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM101-4222
Device description
Guilford-Wright Stapes Pick, heavy,
Published
2023-09-28
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
JYTPICK, MICROSURGICAL EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776043841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776043841001907760438411907760438410190776043841

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear pickA fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. 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
09348811111906INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811112002INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-16
09348811150288INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
09348811150356INKAThe Trustee for KAISER FAMILY TRUSTJYT2026-03-09
00757770682539Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
00757770714049Bausch + LombBausch & Lomb IncorporatedJYT2026-02-11
09348811112040INKAThe Trustee for KAISER FAMILY TRUSTJYT2025-12-02
00757770688531Bausch + LombBausch & Lomb IncorporatedJYT2025-11-14
00757770406821Bausch + LombBausch & Lomb IncorporatedJYT2025-08-05
00757770407613Bausch + LombBausch & Lomb IncorporatedJYT2025-08-05
00757770404346Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770405725Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770407644Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770407774Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770413157Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770414628Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770416158Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770417025Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770417681Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770418190Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770424856Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770425273Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770433520Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770435425Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770435883Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770436613Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00757770436651Bausch + LombBausch & Lomb IncorporatedJYT2025-08-04
00194613021733MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01
00194613021825MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01
00194613021832MSI Precision Specialty InstrumentsMed Saver, Inc.JYT2025-08-01