FDA.report

Avalign

Primary DI
00190776294458
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM91-3286
Device description
Gills-Welsh Lens Loop,
Published
2023-11-15
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
HNESnare, enucleating

Product Code Classifications

CodeDeviceSpecialtyClass
HNESnare, EnucleatingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776294458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776294458001907762944581907762944580190776294458

GMDN Terms

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
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
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