FDA.reportPublic FDA data

Avalign

Primary DI
00190776140328
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM46-0251
Device description
Puncture Needle
Published
2019-08-01
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
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776140328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776140328001907761403281907761403280190776140328

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, reusableA flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. 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
24026704934595PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934601PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
24026704934618PILLINGTELEFLEX INCORPORATEDGDM2026-03-06
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLEW.H. Holden, Inc.GDM2026-01-15
04059453120823Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-12-05
04059453124135Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDM2025-08-25
00810130455386Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00810130455393Medco ManufacturingMedco Manufacturing LLCGDM2025-08-07
00194613120238MSI Precision Specialty InstrumentsMed Saver, Inc.GDM2025-08-01
00810130455300Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455317Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455324Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455331Medco ManufacturingMedco Manufacturing LLCGDM2025-07-18
00810130455218Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455225Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455232Medco ManufacturingMedco Manufacturing LLCGDM2025-06-27
00810130455164Medco ManufacturingMedco Manufacturing LLCGDM2025-06-17
00810130455140Medco ManufacturingMedco Manufacturing LLCGDM2025-06-10
00190776401139MillenniumAvalign Technologies, Inc.GDM2025-06-09
D92810613410SUCTION TIP THREADED #4 W/ HOLEW.H. Holden, Inc.GDM2025-05-21
00810130455003Medco ManufacturingMedco Manufacturing LLCGDM2025-05-06
00192896121492Heparin Olive Tip Needle CannulaSONTEC INSTRUMENTS, INC.GDM2025-04-22
00810130454976Medco ManufacturingMedco Manufacturing LLCGDM2025-04-04
00810130454907Medco ManufacturingMedco Manufacturing LLCGDM2025-03-27
00840516142685Anodyne SurgicalPsi/Eye-Ko, Inc.GDM2025-02-28
00819127023515Tulip Medical Products Reusable CannulasTulip Medical ProductsGDM2025-02-05
00810130454662Medco ManufacturingMedco Manufacturing LLCGDM2024-12-19
00810130454631Medco ManufacturingMedco Manufacturing LLCGDM2024-12-18
D928106121D450SUCTION TIP #1 REGULAR, 9 IN. LENGTH, 1MM, 45 DEGREE DOWN GRINDW.H. Holden, Inc.GDM2024-12-18
D928106121HV20SUCTION TIP #1 HI VOLUME B-STYLE, 9 IN. LENGTH, 1MMW.H. Holden, Inc.GDM2024-12-18