FDA.reportPublic FDA data

Avalign

Primary DI
00190776227777
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM105-2116
Device description
Barnhill Adenoid 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
KBJCURETTE, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBJCurette, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776227777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776227777001907762277771907762277770190776227777

GMDN Terms#

Term, Definition table
TermDefinition
Adenoid curette, reusableA hand-held manual surgical instrument designed for cutting and excising adenoid tissue (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy (adenectomy). It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge that is used to facilitate the removal of the tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the adenoids. 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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613048723MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048730MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048747MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048754MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048778MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048792MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048808MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048822MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048839MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048846MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048877MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613057329MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613068820MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613124014MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
04049047340003GimmiGimmi GmbHKBJ2025-05-22
04049047340010GimmiGimmi GmbHKBJ2025-05-22
04049047340027GimmiGimmi GmbHKBJ2025-05-22
04049047340034GimmiGimmi GmbHKBJ2025-05-22
04049047371595GimmiGimmi GmbHKBJ2025-05-22
04049047371601GimmiGimmi GmbHKBJ2025-05-22
04049047385509GimmiGimmi GmbHKBJ2025-05-22
04049047385516GimmiGimmi GmbHKBJ2025-05-22
04049047387497GimmiGimmi GmbHKBJ2025-05-22
00194613048709MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048716MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048761MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048815MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048860MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00840183507268BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10
00840183512446BR Surgical, LLCBR Surgical, LLCKBJ2024-06-10