FDA.reportPublic FDA data

Millennium

Primary DI
00190776184483
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-T1436
Device description
CUST FINE DOUBLE MESH STRAINER DIAMETER
Published
2021-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KEYSTAINER, TISSUE, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEYStainer, Tissue, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776184483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776184483001907761844831907761844830190776184483

GMDN Terms#

Term, Definition table
TermDefinition
Urine strainerA device designed to collect stones (calculi) from urine during normal micturition (urination). It is typically designed as a sieve-like container with handles for holding and emptying, and is typically mounted into a funnel/holder system that may be attached to a dedicated treatment table or chair. The collected stones are typically sent to the clinical laboratory for examination and composition determination to facilitate patient diagnosis and/or therapy. 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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776385194MillenniumAvalign Technologies, Inc.KEY2024-08-26
00810119676283Xmatrx® EliteBIOGENEX LABORATORIESKEY2023-04-20
00810119676290Xmatrx® InfinityBIOGENEX LABORATORIESKEY2023-04-20
00810119676306Xmatrx® MINIBIOGENEX LABORATORIESKEY2023-04-20
00810119676313NanoVIP®BIOGENEX LABORATORIESKEY2023-04-20
00810119676320i6000™ InfinityBIOGENEX LABORATORIESKEY2023-04-20
00810119676337i6000™ DiagnosticsBIOGENEX LABORATORIESKEY2023-04-20
00810119676368Xmatrx® NanoBIOGENEX LABORATORIESKEY2023-04-20
00884999048843VP2000ABBOTT MOLECULAR INC.KEY2023-02-13
00884999048478VP2000ABBOTT MOLECULAR INC.KEY2019-10-31
00884999047310VP2000ABBOTT MOLECULAR INC.KEY2018-06-01
00884999046108VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046115VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046122VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046146VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046153VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999001916VP2000ABBOTT MOLECULAR INC.KEY2015-02-20
00884999037595VP2000ABBOTT MOLECULAR INC.KEY2015-02-20