FDA.reportPublic FDA data

Millennium

Primary DI
00190776357634
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-7260
Device description
Apt Muscle Clamp
Published
2023-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOBClamp, muscle, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOBClamp, Muscle, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776357634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776357634001907763576341907763576340190776357634

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. 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
00190776391683CONDUIT ZERO-P VA4514021002026-07-10
00190776391690CONDUIT ZERO-P VA4514021102026-07-10
00190776391706CONDUIT ZERO-P VA4514021202026-07-10
00190776391713CONDUIT ZERO-P VA4514030502026-07-10
00190776391720CONDUIT ZERO-P VA4514030602026-07-11
00190776391737CONDUIT ZERO-P VA4514030702026-07-11
00190776391744CONDUIT ZERO-P VA4514030802026-07-11
00190776391751CONDUIT ZERO-P VA4514030902026-07-11
00190776391768CONDUIT ZERO-P VA4514031002026-07-11
00190776391775CONDUIT ZERO-P VA4514031102026-07-11
00190776391782CONDUIT ZERO-P VA4514031202026-07-11
00190776391799CONDUIT ZERO-P VA4515010502026-07-11
00190776391805CONDUIT ZERO-P VA4515010602026-07-11
00190776391812CONDUIT ZERO-P VA4515010702026-07-11
00190776391829CONDUIT ZERO-P VA4515010802026-07-11
00190776391836CONDUIT ZERO-P VA4515010902026-07-11
00190776391843CONDUIT ZERO-P VA4515011002026-07-11
00190776391850CONDUIT ZERO-P VA4515011102026-07-11
00190776391867CONDUIT ZERO-P VA4515011202026-07-11
00190776391874CONDUIT ZERO-P VA4515020502026-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770406036Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770409952Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770420872Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00757770522712Bausch + LombBausch & Lomb IncorporatedHOB2025-08-08
00194613007645MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613007652MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613018467MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613039769MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613095048MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613103705MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613104283MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-08-01
00194613007669MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613034313MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613112691MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2025-03-21
00194613043988MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2024-08-15
00194613053826MSI Precision Specialty InstrumentsMed Saver, Inc.HOB2024-08-15
00190776351946MILLENNIUMAvalign Technologies, Inc.HOB2023-09-28
00190776358976MILLENNIUMAvalign Technologies, Inc.HOB2023-09-28
G2239661010Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOB2023-09-28
00841668118139Oph.ForcepsKATENA PRODUCTS, INC.HOB2022-11-16
00841668118146Oph.ForcepsKATENA PRODUCTS, INC.HOB2022-11-16
00190776076115AvalignAvalign Technologies, Inc.HOB2021-11-03
04049368069119N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069133N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069157N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069171N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069232N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069294N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069355N.A.Geuder AktiengesellschaftHOB2021-02-23
04049368069379N.A.Geuder AktiengesellschaftHOB2021-02-23