FDA.reportPublic FDA data

Millennium

Primary DI
00190776436339
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-310P32425
Device description
Breisky Vaginal Retractor
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDLRetractor, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776436339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776436339001907764363391907764363390190776436339

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776437329Millennium1-803EB2026-11-02
00190776437336Millennium1-80111EB2026-11-02
00190776437343Millennium1-750EB2026-11-02
00190776437350Millennium1-911172026-11-02
00190776437367Millennium1-BIO11042C2026-11-02
00190776437374Millennium1-SS937182026-11-02
00190776437381Millennium1-620030012026-11-02
00190776437398Millennium1-3104952026-11-02
00190776437404Millennium1-1852312026-11-02
00190776437411Millennium1-1851962026-11-02
00190776437428Millennium72-2358702042026-11-02
00190776437435Millennium72-2358702012026-11-02
00190776437442Millennium1-1103332026-11-02
00190776437459Millennium1-500135L2026-11-02
00190776437466Millennium1-2302142026-11-02
00190776437237Millennium1-121195EB2026-10-30
00190776437244Millennium1-018EB2026-10-30
00190776437251Millennium1-010EB2026-10-30
00190776437268Millennium1-7772EB2026-10-30
00190776437275Millennium1-7082EB2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437268MillenniumAvalign Technologies, Inc.HDL2026-10-30
00190776436773MillenniumAvalign Technologies, Inc.HDL2026-10-21
00190776434540MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776434557MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776434564MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776434571MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776435905MillenniumAvalign Technologies, Inc.HDL2026-09-30
00190776431280MillenniumAvalign Technologies, Inc.HDL2026-09-22
00190776432126MillenniumAvalign Technologies, Inc.HDL2026-09-22
00190776432133MillenniumAvalign Technologies, Inc.HDL2026-09-22
00190776423957MillenniumAvalign Technologies, Inc.HDL2026-08-27
00190776407421MillenniumAvalign Technologies, Inc.HDL2026-07-31
00190776400507MillenniumAvalign Technologies, Inc.HDL2026-07-19
15060557440317Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440423Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440430Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440447Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440454Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440062Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440147Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
25060557440154Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
45060557440066Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
65060557440060Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-09
15060557440300Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440393Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
25060557440055Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
45060557440059Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
65060557440053Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-04-02
15060557440003Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26
15060557440072Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26