FDA.report

MILLENNIUM

Primary DI
00190776358976
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-7250
Device description
Apt Muscle Clamp
Published
2023-09-28
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

Related Records

Product Codes

CodeName
HOBClamp, muscle, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HOBClamp, Muscle, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776358976PrimaryGS10

GMDN Terms

TermDefinition
Eye muscle clampAn hand-held manual ophthalmic surgical instrument designed to atraumatically grasp and hold the extraocular muscles (EOM) during an ophthalmic surgical intervention. It is made of high-grade stainless steel and is available in various sizes and designs. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.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

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00190776417925Millennium72-3752532026-03-23
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00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes

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
00190776357634MillenniumAvalign Technologies, Inc.HOB2023-11-17
00190776351946MILLENNIUMAvalign 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