FDA.reportPublic FDA data

Millennium

Primary DI
00190776396411
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-230084LH
Device description
Rongeur Raptor Jr, straight, 2.7mm dia, 95mm length, loop handle
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776396411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776396411001907763964111907763964110190776396411

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190396NAPACIFIC INSTRUMENTS, INC.HTX2026-06-26
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
00846338005719ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
B382SD9238331020Surgical DirectSurgical Direct, Inc.HTX2024-06-25
G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
B382SD921220120Surgical DirectSurgical Direct, Inc.HTX2022-12-01
07640178988750JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640178988767JULIET ® INSTRUMENTATIONSpineArt SAHTX2019-01-15
07640185340602SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340787SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340794SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340800SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340817SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
07640185340824SCARLET AL-T INSTRUMENTATIONSpineArt SAHTX2018-12-10
00192896078819FERRIS-SMITH KERRISONSONTEC INSTRUMENTS, INC.HTX2018-09-20
10381780194521Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194538Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02
10381780194545Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHTX2018-04-02