FDA.reportPublic FDA data

Millennium

Primary DI
00190776432331
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-83110020
Device description
Ferris Smith IVD Rong 10" Shaft 2mm x 10mm
Published
2026-09-24
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776432331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776432331001907764323311907764323310190776432331

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24
00190776432454Millennium72-5223679C12026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250325493537VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301713VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301720VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301737VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301744VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301751VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301836VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301843VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301850VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301867VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301874VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301959VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301966VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301973VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301980VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301997VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302079VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302086VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302109VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302116VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302123VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302130VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302147VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302154VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302161VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302178VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302185VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302192VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302260VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302277VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22