FDA.reportPublic FDA data

Millennium

Primary DI
00190776436773
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-321802E
Device description
LASER BLACK JACKSON VAGINAL RETRACTORS, SINGLE END, MEDIUM, 3.5” X 1.5” (90 X 38MM)
Published
2026-10-21
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
HDLRetractor, Vaginal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776436773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776436773001907764367731907764367730190776436773

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of 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
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
00190776436827Millennium72-3130082OLY2026-10-22
00190776436834Millennium1-1211272026-10-22
00190776436841Millennium63-AOCOMES2026-10-22
00190776436858Millennium100-S03420NSR2026-10-22
00190776436865Millennium1-5255722026-10-22
00190776436872Millennium1-2952026-10-22
00190776436889Millennium1-5053282026-10-22
00190776436896Millennium1-5165062026-10-22
00190776423070Millennium72-4712050SE2026-10-21
00190776435615Millennium72-B9920FADSW2026-10-21
00190776435622Millennium72-B9910FADSW2026-10-21
00190776435639Millennium1-5109332026-10-21
00190776435646Millennium1-5054322026-10-21
00190776435653Millennium72-3295803E2026-10-21
00190776435660Millennium72-1832032026-10-21
00190776435677Millennium72-5225549I2026-10-21
00190776435684Millennium72-31300422026-10-21
00190776435691Millennium1-6158INS2026-10-21
00190776435707Millennium63-5046912026-10-21
00190776435714Millennium63-G120312026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436339MillenniumAvalign Technologies, Inc.HDL2026-10-08
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
15060557440089Galaxy II Surgical RetractorMOSAIC SURGICAL LIMITEDHDL2026-03-26