FDA.reportPublic FDA data

Millennium

Primary DI
00190776388270
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-516536
Device description
Guyon Urethral Sound 36fr
Published
2024-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHMSound, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776388270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776388270001907763882701907763882700190776388270

GMDN Terms#

Term, Definition table
TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. 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
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
00194613017545MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613085841MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613111083MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00190776405670MillenniumAvalign Technologies, Inc.HHM2025-07-18
00190776405687MillenniumAvalign Technologies, Inc.HHM2025-07-18
05010058179585InstrapacROBINSON HEALTHCARE LIMITEDHHM2025-05-21
04049047064725GimmiGimmi GmbHHHM2025-05-20
04049047064923GimmiGimmi GmbHHHM2025-05-20
04049047045267GimmiGimmi GmbHHHM2025-05-14
04049047045328GimmiGimmi GmbHHHM2025-05-14
00190776394882MillenniumAvalign Technologies, Inc.HHM2025-05-08
00190776393175MillenniumAvalign Technologies, Inc.HHM2025-05-05
00194613033750MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613082673MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613087029MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613099855MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
05060212057563Sims Uterine SoundDTR MEDICAL LIMITEDHHM2024-10-14
10841742149124HNM MEDICALHNM STAINLESS, LLC.HHM2024-08-30
00190776384906MillenniumAvalign Technologies, Inc.HHM2024-08-26
00840343722890GEN2SURGIX MEDICAL LLCHHM2024-06-28
00840183525828BR Surgical, LLCBR Surgical, LLCHHM2024-06-04
00810123207183Adler Instrument CompanyAdler, Inc.HHM2024-05-10
04719894432854Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HHM2024-04-08
00840343721978GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840343721985GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840183507121BR Surgical, LLCBR Surgical, LLCHHM2024-03-15
00840183506322BR Surgical, LLCBR Surgical, LLCHHM2024-03-13
00840183506384BR Surgical, LLCBR Surgical, LLCHHM2024-01-30
GYNX43340GynexGYNEX CORPORATIONHHM2023-12-19
GYNX43360GynexGYNEX CORPORATIONHHM2023-12-19