FDA.reportPublic FDA data

Avalign

Primary DI
00190776071899
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM91-8185
Device description
Bowman Probe
Published
2021-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNLProbe, lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNLProbe, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776071899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776071899001907760718991907760718990190776071899

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal probe, reusableA hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090677ELMED INCORPORATEDELMED INCORPORATEDHNL2026-05-12
20757770455953Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00757770460670Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00190776410476MillenniumAvalign Technologies, Inc.HNL2025-09-11
00757770408818Bausch + LombBausch & Lomb IncorporatedHNL2025-08-14
00194613010690MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613010706MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613111731MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
04058935011819Bowman lachrymal probe, 0000-000Bausch & Lomb GmbHHNL2025-07-11
00840343726478GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726485GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726492GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726508GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726515GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726522GEN2SURGIX MEDICAL LLCHNL2025-06-16
G412PH19980MR PHACOCrestpoint Management LimitedHNL2025-06-09
G412PH19600MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19750MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197500MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH1975000MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197510MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197520MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197530MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197540MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19800MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19810MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19820MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19830MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19840MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH19850MR PHACOCrestpoint Management LimitedHNL2025-06-07