FDA.reportPublic FDA data

mytaMed

Primary DI
B351707650
Brand
mytaMed
Company
Mytamed, Inc.
Model
7.07.65
Catalog number
7.07.65
Device description
Sinus Curette, Straight Shaft, Angled Oval Cup
Published
2018-12-19
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KAOCurette, Ethmoid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAOCurette, EthmoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B351707650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus curetteA slender, hand-held, manual surgical instrument designed for scraping and/or excising tissue from one of the paranasal sinuses (i.e., frontal, sphenoidal, ethmoidal, maxillary). The distal end of the instrument is finished in an appropriate shape (e.g., cup-, ring-, spoon-like) according to the procedure to be performed; the device is typically made of high-grade stainless steel and is available in a variety of shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015903922
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
B351BMLGA4X6AC0BEARMLGA4X6ACMLGA4X6AC2021-02-09
B351BMLGA4X6ST0BEARMLGA4X6STMLGA4X6ST2021-02-09
B351BMLGA4X7AC0BEARMLGA4X7ACMLGA4X7AC2021-02-09
B351BMLGA4X7ST0BEARMLGA4X7STMLGA4X7ST2021-02-09
B351BMLGO4X6AC0BEARMLGO4X6ACMLGO4X6AC2021-02-09
B351BMLGO4X6ST0BEARMLGO4X6STMLGO4X6ST2021-02-09
B351BMLGO4X7AC0BEARMLGO4X7ACMLGO4X7AC2021-02-09
B351BMLGO4X7ST0BEARMLGO4X7STMLGO4X7ST2021-02-09
B351BMLGS4X6AC0BEARMLGS4X6ACMLGS4X6AC2021-02-09
B351BMLGS4X7AC0BEARMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7AC0mytaMedMLGA4X7ACMLGA4X7AC2021-02-09
B351MLGO4X7AC0mytaMedMLGO4X7ACMLGO4X7AC2021-02-09
B351MLGO4X7ST0mytaMedMLGO4X7STMLGO4X7ST2021-02-09
B351MLGS4X7AC0mytaMedMLGS4X7ACMLGS4X7AC2021-02-09
B351MLGA4X7ST0mytaMedMLGA4X7STMLGA4X7ST2020-12-14
B351BMLGS4X6ST0BEARMLGS4X6STMLGS4X6ST2020-05-13
B351BMLGS4X7ST0BEARMLGS4X7STMLGS4X7ST2020-05-13
B351MLGS4X7ST0mytaMedMLGS4X7STMLGS4X7ST2020-05-13
B351MLGA4X6AC0mytaMedMLGA4X6ACMLGA4X6AC2018-02-16
B351MLGA4X6ST0mytaMedMLGA4X6STMLGA4X6ST2018-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776420772MillenniumAvalign Technologies, Inc.KAO2026-04-30
00190776418458MillenniumAvalign Technologies, Inc.KAO2026-03-25
00190776418465MillenniumAvalign Technologies, Inc.KAO2026-03-25
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
00190776046552AvalignAvalign Technologies, Inc.KAO2023-09-28
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
14026704806703PILLINGTELEFLEX INCORPORATEDKAO2022-12-08