FDA.reportPublic FDA data

Millennium

Primary DI
00190776434724
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-321603SS
Device description
LATERAL WALL VAGINAL RETRACTOR,GOLD PLATED RATCHET HANDLE-OPEN SHANKS-10.5 in OVERALL LENGTH,3.5in X 1in BLADE SIZE
Published
2026-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDFSpeculum, Vaginal, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776434724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776434724001907764347241907764347240190776434724

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
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
00190776437350MillenniumAvalign Technologies, Inc.HDF2026-11-02
00190776437459MillenniumAvalign Technologies, Inc.HDF2026-11-02
00850090726072Intrace USAPILOTIS TECH LLCHDF2026-10-31
00850090726249Intrace USAPILOTIS TECH LLCHDF2026-10-31
00850090726256Intrace USAPILOTIS TECH LLCHDF2026-10-31
00850090726263Intrace USAPILOTIS TECH LLCHDF2026-10-31
00190776436964MillenniumAvalign Technologies, Inc.HDF2026-10-23
00190776436971MillenniumAvalign Technologies, Inc.HDF2026-10-23
00190776436988MillenniumAvalign Technologies, Inc.HDF2026-10-23
B382SD915070010Surgical DirectSurgical Direct, Inc.HDF2026-10-20
B382SD915070020Surgical DirectSurgical Direct, Inc.HDF2026-10-20
B382SD915070030Surgical DirectSurgical Direct, Inc.HDF2026-10-20
00190776434731MillenniumAvalign Technologies, Inc.HDF2026-10-12
00190776434809MillenniumAvalign Technologies, Inc.HDF2026-10-12
00190776428150MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428181MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428198MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428242MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776419622MillenniumAvalign Technologies, Inc.HDF2026-08-23
B382SD915039080Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039140Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039150Surgical DirectSurgical Direct, Inc.HDF2026-08-21
00190776426439MillenniumAvalign Technologies, Inc.HDF2026-08-18
00190776426446MillenniumAvalign Technologies, Inc.HDF2026-08-18
00198506093944ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094088ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094095ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094101ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094118ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00850088713534PRINCETONPrinceton Medical Group, Inc.HDF2026-08-14