FDA.reportPublic FDA data

Millennium

Primary DI
00190776172114
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
1-121212
Device description
CARB-BITE DEBAKEY NEEDLE HOLDER
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776172114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776172114001907761721141907761721140190776172114

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
00198506091124ELMED INCORPORATEDELMED INCORPORATEDGEN2026-05-26
00846159039269SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039276SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039283SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039290SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039306SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039313SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039320SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039337SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039344SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039351SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039368SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039375SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039382SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039399SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039405SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039412SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039429SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039436SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039443SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039450SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039467SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039474SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039481SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039498SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039504SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039511SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039528SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039535SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039542SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26