FDA.reportPublic FDA data

Millennium

Primary DI
00190776307110
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-42649
Device description
"Grooved Director 6"" with tongue tie"
Published
2023-11-17
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
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776307110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776307110001907763071101907763071100190776307110

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological directorA slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. The distal shaft may be straight or curved and the proximal handle formed as a finger grip. 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
00190776437176Millennium1-212EB2026-10-28
00190776437183Millennium1-268EB2026-10-28
00190776437190Millennium1-269EB2026-10-28
00190776437206Millennium1-270-11EB2026-10-28
00190776437213Millennium1-293EB2026-10-28
00190776437220Millennium1-244EB2026-10-28
00190776439811Millenium85-140190932026-10-28
00190776439828Millenium85-710188352026-10-28
00190776439835Millenium85-640033142026-10-28
00190776433796Millennium1-6570502026-10-08
00190776433802Millennium1-6570512026-10-08
00190776433819Millennium1-6570532026-10-08
00190776399221Millennium1-1124282025-05-29
00190776433000Millennium1-161962026-10-26
00190776437060Millennium1-121219-122026-10-26
00190776437077Millennium1-410324C2026-10-26
00190776437084Millennium1-516410-6752026-10-26
00190776437091Millennium1-516420-6752026-10-26
00190776437107Millennium1-516430-6752026-10-26
00190776437114Millennium1-516440-6752026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435875MillenniumAvalign Technologies, Inc.FGM2026-09-30
00190776427825MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427832MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427849MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427856MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427863MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427870MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427887MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427894MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427900MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427917MillenniumAvalign Technologies, Inc.FGM2026-08-26
00192896122826Barr ProbeSONTEC INSTRUMENTS, INC.FGM2026-03-10
00190776416201MillenniumAvalign Technologies, Inc.FGM2026-02-12
00192896122543Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00192896122550Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00190776411831MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411848MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411855MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411862MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411879MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411886MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411893MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411909MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776406325MillenniumAvalign Technologies, Inc.FGM2025-07-21
G453332312160PEAK MEDICALPeak Medical Distribution Inc.FGM2025-06-17
00190776399993MillenniumAvalign Technologies, Inc.FGM2025-06-03
04049047024422GimmiGimmi GmbHFGM2025-05-06
G4533352001180PEAK MEDICALPeak Medical Distribution Inc.FGM2025-01-20
G586G91027310Novo SurgicalNOVO SURGICAL, INC.FGM2024-10-15
04049197272230RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20