FDA.reportPublic FDA data

Millennium

Primary DI
00190776372200
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
75-352816
Device description
Spencer Mitral Valve Rongeur
Published
2023-05-09
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776372200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776372200001907763722001907763722000190776372200

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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
24026704941593PILLINGTELEFLEX INCORPORATEDDWS2026-03-23
03661219509158DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511618DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511649DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511694DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511809DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511830DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515425DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515968DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528685DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528692DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528708DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528715DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219322184DELACROIX-CHEVALIERLANDANGERDWS2026-03-16
03661219323747DELACROIX-CHEVALIERLANDANGERDWS2026-03-13
04058749009538NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009811NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009873NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009903NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043082NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043099NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043143NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043150NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043167NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749047752NAFehling Instruments GmbH & Co. KGDWS2026-03-05
00198506088957ELMED INCORPORATEDELMED INCORPORATEDDWS2026-03-03
03661219010296LANDANGERLANDANGERDWS2026-03-02
03661219138471DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138518DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138556DELACROIX-CHEVALIERLANDANGERDWS2026-03-02