FDA.reportPublic FDA data

Millennium

Primary DI
00190776397715
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-136101
Device description
"Reverdin Needle 7 1/2"" #1 curved"
Published
2025-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDLNeedle, Suturing, Reusable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDLNeedle, Suturing, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776397715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776397715001907763977151907763977150190776397715

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. This is a reusable device intended to be sterilized prior to use.

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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613031718MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613040130MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613054878MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613084950MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112493MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112509MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112622MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613112684MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613113308MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119843MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119850MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119874MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119881MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119898MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613119911MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121129MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00194613121136MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-08-01
00190776401764MillenniumAvalign Technologies, Inc.GDL2025-06-13
00194613106218MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613114237MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119867MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119904MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00194613119928MSI Precision Specialty InstrumentsMed Saver, Inc.GDL2025-03-21
00190776390716MillenniumAvalign Technologies, Inc.GDL2024-11-19
G586OP7121290Novo SurgicalNOVO SURGICAL, INC.GDL2024-10-15
04049197022682RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-10-02
04049197022699RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-10-02
04049197455718RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-09-20
04049197455725RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-09-20
04049197466295RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDL2024-09-20