FDA.reportPublic FDA data

Avalign

Primary DI
00190776227128
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-6889
Device description
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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAPCURETTE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAPCurette, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776227128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776227128001907762271281907762271280190776227128

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use 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
09348811100368INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-28
09348811100382INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
09348811100979INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
00757770668410Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770684618Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770422944Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770424764Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770425716Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770431182Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434046Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434640Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770403004Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770406562Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770410859Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770411962Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770418589Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770419845Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770420506Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770422630Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770402779Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770403776Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770404483Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770406586Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770420360Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770423088Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00887482116203Symmetry PaparellaSYMMETRY SURGICAL INC.KAP2024-09-05
00887482119358Symmetry SurgicalSYMMETRY SURGICAL INC.KAP2024-09-05
00194613068608MSI Precision Specialty InstrumentsMed Saver, Inc.KAP2024-08-15
00840183527327BR Surgical, LLCBR Surgical, LLCKAP2024-07-16
00840183522537BR Surgical, LLCBR Surgical, LLCKAP2024-06-03