FDA.reportPublic FDA data

Avalign

Primary DI
00190776069681
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM91-3281
Device description
Wilder Lens Loop, Serrated,
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNESnare, enucleating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNESnare, EnucleatingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776069681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776069681001907760696811907760696810190776069681

GMDN Terms#

Term, Definition table
TermDefinition
Lens loop, reusableA hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device.

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
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770417810Bausch + LombBausch & Lomb IncorporatedHNE2024-11-19
00757770403042Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770403684Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770403950Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770404568Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770405701Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770407149Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770408511Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410019Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410286Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770410965Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411092Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411252Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411696Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770411993Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413065Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413126Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770413706Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770415205Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770417384Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770417759Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420216Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420261Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770420537Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421084Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421763Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770421978Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770422449Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423262Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26
00757770423477Bausch + LombBausch & Lomb IncorporatedHNE2024-08-26