FDA.reportPublic FDA data

Millennium

Primary DI
00190776400491
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-22003663
Device description
Rasps Round Handle
Published
2026-07-17
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
KBARasp, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBARasp, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776400491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776400491001907764004911907764004910190776400491

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological excimer laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power ultraviolet laser beam (UVA and/or UVB) intended for dermal phototherapy. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It is typically intended to treat disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.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
00190776400255Millennium85-770394842026-07-17
00190776400279Millennium85-612145882026-07-17
00190776400286Millennium85-650123442026-07-17
00190776400293Millennium85-650124292026-07-17
00190776400309Millennium85-530182002026-07-17
00190776400316Millennium85-640256632026-07-17
00190776400323Millennium85-642056792026-07-17
00190776400330Millennium85-140309902026-07-17
00190776400347Millennium85-500031652026-07-17
00190776400354Millennium85-640048772026-07-17
00190776400361Millennium85-140193092026-07-17
00190776400378Millennium85-710076432026-07-17
00190776400385Millennium85-710041182026-07-17
00190776400392Millennium85-430112722026-07-17
00190776400408Millennium12-8015252026-07-17
00190776400415Millennium12-8015242026-07-17
00190776400422Millennium85-220009752026-07-17
00190776400439Millennium85-220009792026-07-17
00190776400446Millennium85-230835912026-07-17
00190776400453Millennium85-170101252026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800256Adler Instrument CompanyAdler, Inc.KBA2026-05-26
00190776420147MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420154MillenniumAvalign Technologies, Inc.KBA2026-04-16
00190776420161MillenniumAvalign Technologies, Inc.KBA2026-04-16
14026704941688PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
24026704941685PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
09348811102744INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103246INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103253INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103260INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
G043662100BEARBear-Ent, LLCKBA2025-10-08
04250676732187Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676732194Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676740229Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
04250676740236Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
00190776409920MillenniumAvalign Technologies, Inc.KBA2025-09-08
00194613032586MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032616MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032623MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032647MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032661MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032685MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613047887MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110314MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110321MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613111236MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613116941MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613117115MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613117849MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613119737MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01