FDA.reportPublic FDA data

Millennium

Primary DI
00190776422141
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-5200108E
Device description
Schroeder Vulsellum Double Tooth Tenaculum w/ Ratchet EBONIZED
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00190776422141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776422141001907764221411907764221410190776422141

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
00190776407537Millennium85-900114502026-08-03
00190776407544Millennium85-220032892026-08-03
00190776407551Millennium85-200771242026-08-03
00190776407568Millennium85-440133392026-08-03
00190776408619Millennium9-8123302026-08-03
00190776408626Millennium85-500021432026-08-03
00190776408633Millennium85-528030162026-08-03
00190776408640Millennium85-668484472026-08-03
00190776408664Millennium85-650059602026-08-03
00190776408671Millennium85-220140482026-08-03
00190776408688Millennium85-780029742026-08-03
00190776408695Millennium85-600048132026-08-03
00190776408718Millennium85-250056502026-08-03
00190776408725Millennium85-600098002026-08-03
00190776408732Millennium85-160225992026-08-03
00190776408749Millennium85-710033452026-08-03
00190776408756Millennium85-620453222026-08-03
00190776408763Millennium85-120145262026-08-03
00190776408817Millennium85-310P447392026-08-03
00190776408824Millennium85-710026302026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422721MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422769MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422790MillenniumAvalign Technologies, Inc.GEN2026-08-03
B382SD4829170Surgical DirectSurgical Direct, Inc.GEN2026-08-03
00190776422226MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422233MillenniumAvalign Technologies, Inc.GEN2026-07-31
B382SD1426525010Surgical DirectSurgical Direct, Inc.GEN2026-07-31
B382SD1426525020Surgical DirectSurgical Direct, Inc.GEN2026-07-31
00810143904840SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904857SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904864SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909227SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909715SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909746SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934860SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934877SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934884SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934891SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935362SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935379SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935546SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935553SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935560SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935584SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935591SURGIPROSSurgipros, LLCGEN2026-07-30
00810212935669SURGIPROSSurgipros, LLCGEN2026-07-30
B382SD919327220Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919327230Surgical DirectSurgical Direct, Inc.GEN2026-07-29
B382SD919523070Surgical DirectSurgical Direct, Inc.GEN2026-07-29