FDA.reportPublic FDA data

Millennium

Primary DI
00190776149871
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
18-ABB3A
Device description
Artery Approx Clamp, dbl, double, w/ frame, matte, artery size 1.0mm-2.25mm
Published
2019-11-22
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
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776149871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776149871001907761498711907761498710190776149871

GMDN Terms#

Term, Definition table
TermDefinition
Surgical bulldog clamp, reusableA hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping however it is not dedicated to a specific anatomy/surgery. This is a reusable device intended to be sterilized prior to use.

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
true
Premarket exempt
false
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
20197344138897NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
00192896122697Cooley Vascular ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122710Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122727Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00884450846032Safeguard Radial™Merit Medical Systems, Inc.DXC2026-02-20
00840479401027enableCV IntraClude™ Intra-Aortic Occlusion DeviceENABLECV INC.DXC2026-02-06
18022057015881DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015891DeTACH Aortic Cross Clamp Head- MediumCORCYM SRLDXC2026-02-03
18022057015904DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
08022057015914DeTACH Aortic Cross Clamp Delivery SystemCORCYM SRLDXC2026-02-03
08022057015921DeTACH Aortic Cross Clamp Quick Release DeviceCORCYM SRLDXC2026-02-03
08022057015945DeTACH Aortic Cross Clamp Delivery DeviceCORCYM SRLDXC2026-02-03
00810123209507Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209514Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209521Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209538Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209545Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209552Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209583Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209590Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209606Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209613Adler Instrument CompanyAdler, Inc.DXC2025-08-19
54026704930840PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930857PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930864PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930871PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930888PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930895PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
00192896121638Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17
00192896121645Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17