FDA.reportPublic FDA data

Millennium

Primary DI
00190776408671
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-22014048
Device description
Cottle-Kazanjian Cutting Forcep
Published
2026-08-03
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
KAEForceps, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776408671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776408671001907764086711907764086710190776408671

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutting forceps, reusableA strongly constructed, hand-held, surgical instrument used for cutting posterior rib ends and bone tissue during a surgical procedure. It typically has very strong, sharp, angled cutting blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the blades so that they cut entirely through the bone. It is available in various sizes and is made of high-grade stainless steel. This is a reusable device.

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
00190776407537Millennium85-900114502026-08-03
00190776407544Millennium85-220032892026-08-03
00190776407551Millennium85-200771242026-08-03
00190776407568Millennium85-440133392026-08-03
00190776408619Millennium9-8123302026-08-03
00190776408626Millennium85-500021432026-08-03
00190776408633Millennium85-528030162026-08-03
00190776408640Millennium85-668484472026-08-03
00190776408664Millennium85-650059602026-08-03
00190776408688Millennium85-780029742026-08-03
00190776408695Millennium85-600048132026-08-03
00190776408718Millennium85-250056502026-08-03
00190776408725Millennium85-600098002026-08-03
00190776408732Millennium85-160225992026-08-03
00190776408749Millennium85-710033452026-08-03
00190776408756Millennium85-620453222026-08-03
00190776408763Millennium85-120145262026-08-03
00190776408817Millennium85-310P447392026-08-03
00190776408824Millennium85-710026302026-08-03
00190776408831Millennium85-230915672026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422486MillenniumAvalign Technologies, Inc.KAE2026-07-31
00810143907834SURGIPROSSurgipros, LLCKAE2026-07-31
B382SD9196141000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9196141010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421000Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421010Surgical DirectSurgical Direct, Inc.KAE2026-07-29
B382SD9202421020Surgical DirectSurgical Direct, Inc.KAE2026-07-29
00190776405908MillenniumAvalign Technologies, Inc.KAE2026-07-26
00190776404147MillenniumAvalign Technologies, Inc.KAE2026-07-24
00190776403874MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403911MillenniumAvalign Technologies, Inc.KAE2026-07-22
00190776403782MillenniumAvalign Technologies, Inc.KAE2026-07-21
04046826110833MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-07-21
00190776402198MillenniumAvalign Technologies, Inc.KAE2026-07-19
00190776395353MillenniumAvalign Technologies, Inc.KAE2026-07-14
00850083275785Intrace USAPILOTIS TECH LLCKAE2026-07-03
00850083275860Intrace USAPILOTIS TECH LLCKAE2026-07-03
04054462923465evonosevonos GmbH & Co. KGKAE2026-06-26
00810220800294Adler Instrument CompanyAdler, Inc.KAE2026-06-02
09348811022066INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-06-02
09348811105417INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-05-29
09348811103796INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104236INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104595INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104908INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104915INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811104953INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105653INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811105707INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24
09348811172099INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-04-24