FDA.reportPublic FDA data

Millennium

Primary DI
00190776393175
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-EF810R
Device description
VanBuren Urethral Sound, 28fr, 10 5/8"
Published
2025-05-05
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
HHMSound, Uterine

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776393175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776393175001907763931751907763931750190776393175

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
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
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

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
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
00190776388270MillenniumAvalign Technologies, Inc.HHM2024-11-13
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