FDA.reportPublic FDA data

Millennium

Primary DI
00190776432546
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-031700
Device description
Synovectomy Rongeur Slight Cuve 2mm Ring Handle
Published
2026-09-28
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776432546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776432546001907764325461907764325460190776432546

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
00190776436827Millennium72-3130082OLY2026-10-22
00190776436834Millennium1-1211272026-10-22
00190776436841Millennium63-AOCOMES2026-10-22
00190776436858Millennium100-S03420NSR2026-10-22
00190776436865Millennium1-5255722026-10-22
00190776436872Millennium1-2952026-10-22
00190776436889Millennium1-5053282026-10-22
00190776436896Millennium1-5165062026-10-22
00190776423070Millennium72-4712050SE2026-10-21
00190776435615Millennium72-B9920FADSW2026-10-21
00190776435622Millennium72-B9910FADSW2026-10-21
00190776435639Millennium1-5109332026-10-21
00190776435646Millennium1-5054322026-10-21
00190776435653Millennium72-3295803E2026-10-21
00190776435660Millennium72-1832032026-10-21
00190776435677Millennium72-5225549I2026-10-21
00190776435684Millennium72-31300422026-10-21
00190776435691Millennium1-6158INS2026-10-21
00190776435707Millennium63-5046912026-10-21
00190776435714Millennium63-G120312026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840642182149Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182156Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
10840642182163Spine Wave InstrumentsSpine Wave, Inc.HTX2026-10-21
B382SD9228132200Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132300Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132310Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132340Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132350Surgical DirectSurgical Direct, Inc.HTX2026-10-20
B382SD9228132360Surgical DirectSurgical Direct, Inc.HTX2026-10-20
00190776435394MillenniumAvalign Technologies, Inc.HTX2026-10-19
00190776434670MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434687MillenniumAvalign Technologies, Inc.HTX2026-10-12
00190776434113MillenniumAvalign Technologies, Inc.HTX2026-10-09
B382SD922779120Surgical DirectSurgical Direct, Inc.HTX2026-10-09
B382SD9228051950Surgical DirectSurgical Direct, Inc.HTX2026-10-09
00190776436360MillenniumAvalign Technologies, Inc.HTX2026-10-08
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD546210000Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131060Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131070Surgical DirectSurgical Direct, Inc.HTX2026-09-29
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321420V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
B382SD482012L0Surgical DirectSurgical Direct, Inc.HTX2025-10-06
00840217909327Wiggins MedicalEBNER MEDICAL, LLCHTX2024-12-09
00840217908924Wiggins MedicalEBNER MEDICAL, LLCHTX2024-03-21