FDA.reportPublic FDA data

Millennium

Primary DI
00190776362522
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
17-016508
Device description
Dolwick-Reich Disc Resection Knife
Published
2023-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKDINSTRUMENT, CUTTING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776362522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776362522001907763625221907763625220190776362522

GMDN Terms#

Term, Definition table
TermDefinition
Tonsil knifeA hand-held manual surgical instrument intended for the removal of the tonsils during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, scythe-like, cutting blade at the distal end (the internal radius of the curve has the cutting edge) which is normally quite small; it has a very long and slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. 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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275662Intrace USAPILOTIS TECH LLCEKD2026-07-03
00348783008333Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008340Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008357Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783012248Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008265Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008272Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008289Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008319Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00840018635838NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635845NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635852NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635869NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635876NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635883NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635890NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635906NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635913NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635920NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635937NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635944NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635951NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635968NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635975NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635982NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635999NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636002NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636019NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636026NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636033NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02