FDA.report

Avalign

Primary DI
00190776076115
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM91-5630
Device description
Putterman Clamp,
Published
2021-11-03
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

Related Records

Contact Domains

Product Codes

CodeName
HOBClamp, muscle, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HOBClamp, Muscle, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776076115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776076115001907760761151907760761150190776076115

GMDN Terms

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
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

Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
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
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
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