FDA.reportPublic FDA data

Millennium

Primary DI
00190776169633
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
1-775-5
Device description
NEEDLE EXTENDER
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
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776169633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776169633001907761696331907761696330190776169633

GMDN Terms#

Term, Definition table
TermDefinition
Luer needle extenderA slim, rigid tube intended to connect to a Luer needle to extend the length of the needle for access to anatomical sites that a standard length needle might not reach. It has a Luer connection at each end and does not incorporate any additional functionality. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03662663161237PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
03662663161961Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2026-02-16
00850031983014OCCIGUIDEVAULT PARAGON GROUP, INC.GDF2026-01-07
03662663244442Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663244466Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663276412Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276429Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276788Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-11-17
03662663135924Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCGDF2025-11-14
20197344044792MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
20197344044808MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
00194613059095MSI Precision Specialty InstrumentsMed Saver, Inc.GDF2025-08-01
10850012846434PicoDriverLSI Solutions, Inc.GDF2025-07-19
05010058179820InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182639InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182646InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058183643InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182622InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-18
05010058178953InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
05010058179943InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
04049047675808GimmiGimmi GmbHGDF2025-05-06
04049047675815GimmiGimmi GmbHGDF2025-05-06
04049047675884GimmiGimmi GmbHGDF2025-05-06
04049047675891GimmiGimmi GmbHGDF2025-05-06
04049047675907GimmiGimmi GmbHGDF2025-05-06
04049047675945GimmiGimmi GmbHGDF2025-05-06
04049047675952GimmiGimmi GmbHGDF2025-05-06
04049047675969GimmiGimmi GmbHGDF2025-05-06
04049047675976GimmiGimmi GmbHGDF2025-05-06