FDA.reportPublic FDA data

Avalign

Primary DI
00190776223069
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-1131
Device description
Coakley Antrum Curette
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776223069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776223069001907762230691907762230690190776223069

GMDN Terms#

Term, Definition table
TermDefinition
Ethmoid curetteA slender, hand-held, manual surgical instrument designed for excision of the ethmoid cells (spaces in the ethmoid sinuses) or a portion of the ethmoid bone (i.e., ethmoidectomy). The instrument typically has two ring-shaped ends that are usually sharp on both sides; it is typically made of high-grade stainless steel. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811100603INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100825INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100832INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-05-29
09348811100559INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100566INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100573INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100818INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100849INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
09348811100856INKAThe Trustee for KAISER FAMILY TRUSTJYG2025-11-21
20888277660196MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660233MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-22
20888277660240MEDLINEMEDLINE INDUSTRIES, INC.JYG2024-11-05
00612479269538McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269569McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00612479269590McKessonMCKESSON MEDICAL-SURGICAL INC.JYG2024-09-09
00194613018269MSI Precision Specialty InstrumentsMed Saver, Inc.JYG2024-08-15
08904461000321OSSEOUS Rosen InserterEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319620OSSEOUS Jobson Horne Probe-RoundEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319637OSSEOUS Jobson Horne Probe-OvalEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319644OSSEOUS Cerumen hookEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
08906039319668OSSEOUS Myringotomy knifeEON MEDITECH PRIVATE LIMITEDJYG2024-07-04
20888277660202MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660219MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660226MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277660257MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20888277669168MedlineMEDLINE INDUSTRIES, INC.JYG2024-05-01
20193489141495MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141501MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141518MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18
20193489141525MedlineMEDLINE INDUSTRIES, INC.JYG2023-12-18