FDA.reportPublic FDA data

Flat-Blade Micro-Ringcurette φ1.0

Primary DI
00883475950687
Brand
Flat-Blade Micro-Ringcurette φ1.0
Company
CHARMANT INC.
Model
31-5137
Published
2023-09-18
Public version status
New
Distribution status
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
00883475950687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883475950687008834759506878834759506870883475950687

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical curette, reusableA hand-held manual surgical instrument intended to be used to scrape and debride tissue from a bone surface (e.g., cancellous vertebral bone of the spine) or a cavity wall during a neurosurgical procedure. It consists of a long, thin, metal shaft that terminates distally into a spoon-, scoop- or mushroom-like cutting head, that can be set at alternative angles, which enables a smooth scoring action for the creation of grooves or channels. It is typically used during percutaneous kyphoplasty to treat vertebral compression fractures (VCFs), or during craniotomy or brain microsurgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
693742728
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883475708523Multi Purpose Forceps37-00352023-09-18
00883475953930Paddle tip Manipulator37-00802023-09-18
00883475953947Ball tip Manipulator37-00812023-09-18
00883475953299MS Round-Crescent-Flat22-01BNJP2024-08-01
00883475953305MS Round-Crescent-Flat22-01BNKP2024-08-01
00883475953312MS Round-ST-Flat22-02BNIP2024-08-01
00883475953329MS Round-ST-Flat22-02BNKP2024-08-01
00883475953411MS Round-ST-CV22-03BNIP2024-08-01
00883475953428MS Round-ST-CV22-03BNKP2024-08-01
00883475951370Pressure Adjustable Micro-Sucker 7S31-50572023-09-18
00883475651300IOL Hook37-00022023-09-18
00883475651324Capsulorrhexis Forceps37-00042023-09-18
00883475651331Micro Scissors(Acute tips)37-00052023-09-18
00883475651348Micro Scissors(Blunt tips)37-00062023-09-18
00883475651355Iris Forceps37-00072023-09-18
00883475651362Needle Holder37-00082023-09-18
00883475651379Wire Speculum37-00092023-09-18
00883475651386Wire Speculum with Blade37-00102023-09-18
00883475679038Micro Forceps CROSS MAX37-00112023-09-18
00883475679045Cilia Forceps CROSS MAX37-00122023-09-18

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
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
14026704809179PILLINGTELEFLEX INCORPORATEDKAO2022-12-08