FDA.report

Avalign

Primary DI
00190776046552
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM104-1116
Device description
Halle Ethmoid 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

Related Records

Contact Domains

Product Codes

CodeName
KAOCURETTE, ETHMOID

Product Code Classifications

CodeDeviceSpecialtyClass
KAOCurette, EthmoidEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776046552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776046552001907760465521907760465520190776046552

GMDN Terms

TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
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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 DIBrandCompanyProduct codePublished
00194613108069MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00194613109585MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00194613116552MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00194613116569MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00198506001666ELMEDELMED INCORPORATEDKAO2024-04-24
G586E7411600Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E7769560Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97499160Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97769230Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97769470Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97769560Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
00842331192531Novo Surgical Inc. NOVO SURGICAL, INC.KAO2023-12-07
00842180179455ELMEDELMED INCORPORATEDKAO2023-10-12
00190776223038AvalignAvalign Technologies, Inc.KAO2023-09-28
00190776322878MILLENNIUMAvalign Technologies, Inc.KAO2023-09-28
00190776322885MILLENNIUMAvalign Technologies, Inc.KAO2023-09-28
00190776322908MILLENNIUMAvalign Technologies, Inc.KAO2023-09-28
00883475950687Flat-Blade Micro-Ringcurette φ1.0CHARMANT INC.KAO2023-09-18
00883475950694Flat-Blade Micro-Ringcurette φ1.5CHARMANT INC.KAO2023-09-18
00883475950717Micro-Curette 0.75×1.0 80deg.CHARMANT INC.KAO2023-09-18
00883475950724Micro-Curette 1.0×2.0 80deg.CHARMANT INC.KAO2023-09-18
00883475950731Micro-Curette 1.5×2.0 30deg.CHARMANT INC.KAO2023-09-18
00883475951714Micro-Curette 0.75×1.5 80deg.CHARMANT INC.KAO2023-09-18
00842962142202HNM MedicalHNM STAINLESS, LLC.KAO2023-04-17
00190776295066MillenniumAvalign Technologies, Inc.KAO2022-12-12
54026704806701PILLINGTELEFLEX INCORPORATEDKAO2022-12-08
54026704809191PILLINGTELEFLEX INCORPORATEDKAO2022-12-08
54026704809177PILLINGTELEFLEX INCORPORATEDKAO2022-12-08
54026704809184PILLINGTELEFLEX INCORPORATEDKAO2022-12-08
00842331186660Novo Surgical Inc. NOVO SURGICAL, INC.KAO2022-11-14