FDA.reportPublic FDA data

Millennium

Primary DI
00190776169527
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
1-293322
Device description
WALTHER FEM. DIL-CATH
Published
2021-11-01
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
GCCDilator, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCCDilator, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776169527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776169527001907761695271907761695270190776169527

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. 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
00850007350338Salivary Access Dilator SetC2DX, INC.GCC2026-02-10
00194613099848MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2025-08-01
00194613094942MSI Precision Specialty InstrumentsMed Saver, Inc.GCC2024-08-15
00840183501945BR Surgical, LLCBR Surgical, LLCGCC2024-01-31
G586UR96282190Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282210Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282230Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282250Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282270Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282290Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
G586UR96282310Novo SurgicalNOVO SURGICAL, INC.GCC2023-12-18
00840343718312GEN2SURGIX MEDICAL LLCGCC2023-09-05
00842331192661Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192678Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192685Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192692Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00842331192708Novo Surgical IncNOVO SURGICAL, INC.GCC2023-08-14
00840329829445Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GCC2023-05-10
00842962125571HNM MEDICALHNM STAINLESS, LLC.GCC2023-04-03
00842962125526HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125533HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125540HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125557HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962125564HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-29
00842962124345HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124352HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124369HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124376HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124383HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23
00842962124390HNM MEDICALHNM STAINLESS, LLC.GCC2023-03-23