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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462901630evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901647evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901654evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901661evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908134evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908141evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908158evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908165evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908172evonosevonos GmbH & Co. KGJYG2026-08-21
04054462908189evonosevonos GmbH & Co. KGJYG2026-08-21
04054462901678evonosevonos GmbH & Co. KGJYG2026-08-18
04054462901685evonosevonos GmbH & Co. KGJYG2026-08-18
00190776422295MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422356MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422363MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422370MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422387MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31
00190776403331MillenniumAvalign Technologies, Inc.JYG2026-07-21
00190776400637MillenniumAvalign Technologies, Inc.JYG2026-07-19
00190776395469MillenniumAvalign Technologies, Inc.JYG2026-07-14
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