FDA.reportPublic FDA data

Millennium

Primary DI
00190776183707
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-35505
Device description
Bunnell Dissecting Probe angled tip, .
Published
2021-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXBPROBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776183707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776183707001907761837071907761837070190776183707

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical probeA non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.

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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
10649111297120SklarSKLAR CORPORATIONHXB2019-03-19
10649111297496SklarSKLAR CORPORATIONHXB2019-03-19
10649111376351Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111376474Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377655Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377785Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111255212Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255342Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255502Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255649Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111176982Sklar®SKLAR CORPORATIONHXB2019-01-24
10649111151477Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111153983Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111155208Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111156847Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111220524Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111220739Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111083389Sklar®SKLAR CORPORATIONHXB2018-10-24
10649111013881Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111018688Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111019470Sklar®SKLAR CORPORATIONHXB2018-09-14