FDA.reportPublic FDA data

Millennium

Primary DI
00190776395353
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-22011785
Device description
Biopsy and Grasping Forcep
Published
2026-07-14
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
00190776395353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776395353001907763953531907763953530190776395353

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. 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
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
00190776395360Millennium85-120P088052026-07-14
00190776395445Millennium85-610149882026-07-14
00190776395469Millennium85-200067112026-07-14
00190776395476Millennium85-760826282026-07-14
00190776395483Millennium85-620343252026-07-14
00190776395490Millennium85-160514552026-07-14
00190776395506Millennium85-780041542026-07-14
00190776395513Millennium85-780041492026-07-14
00190776395520Millennium85-640030002026-07-14
00190776395537Millennium85-200936872026-07-14
00190776395544Millennium85-780027742026-07-14
00190776395551Millennium85-780942452026-07-14
00190776395568Millennium85-200771592026-07-14
00190776395575Millennium85-431123682026-07-14
00190776395582Millennium85-431120402026-07-14
00190776395599Millennium85-780694382026-07-14
00190776395605Millennium85-520029402026-07-14
00190776395629Millennium85-200771522026-07-14
00190776395636Millennium85-320P072422026-07-14
00190776395643Millennium85-510127092026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09348811172112INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-18
G04371902F0BEARBear-Ent, LLCKAE2026-02-12
09348811105400INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-21
09348811129024INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-11-19
08906039316018OSSEOUS Titanium-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316025OSSEOUS Fluoroplastic-Stapes Prosthesis Handling ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316032OSSEOUS Stapes Prosthesis Crimping ForcepsEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039316049OSSEOUS Tilley's Nasal Dressings Forceps EON MEDITECH PRIVATE LIMITEDKAE2024-07-04
08906039319699OSSEOUS Micro Alligator Ear ForcepesEON MEDITECH PRIVATE LIMITEDKAE2024-07-04
G586NS80152710Novo SurgicalNOVO SURGICAL, INC.KAE2024-02-22
07898506842704QuinelatoSchobell Industrial LtdaKAE2023-01-09
10381780406815Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780407072Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-08-16
10381780402855Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03
10381780402862Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKAE2018-05-03