FDA.reportPublic FDA data

Millennium

Primary DI
00190776416676
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-9821F
Device description
"Right Angle Fiber-Optic Retr 1"" x 6'' Smooth Black Plastic Handle Non-Slip"
Published
2026-02-16
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776416676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776416676001907764166761907764166760190776416676

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic retractor handleA hand-held surgical instrument with an integral fibreoptic bundle intended to accept a retractor blade (not included) to: 1) enable manipulation of the blade during non-self-retaining surgical retraction of tissues; and 2) provide illumination of deep surgical sites typically during abdominal or pelvic surgical procedures. The fibreoptic bundle is attached to a separate light source, typically via a light-source cable, to produce illumination. 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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432331Millennium1-831100202026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
B7683361430Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683363220Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683439140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-24
B7682462200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-23
B7682461610Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685612810Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685255060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255120Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257350Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257670Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255190Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685257320Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685612550Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-07-23
B7685661130Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-06-13
B7682460140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30
B7683359530Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30