FDA.reportPublic FDA data

Avalign

Primary DI
00190776006495
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM59-2606
Device description
McGivney h Ligator includes cone and o-rings
Published
2017-03-23
Public version status
Update
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
FHNLigator, hemorrhoidal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHNLigator, HemorrhoidalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776006495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776006495001907760064951907760064950190776006495

GMDN Terms#

Term, Definition table
TermDefinition
Haemorrhoid ligatorA hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

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
true
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
true
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
00860014651113LHC Power Bander LHC Power Bander LLCFHN2026-03-03
16932503532850Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532867Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532874Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532881Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532898Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532904Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532911Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532935Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
16932503532942Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-02-14
08033638801727Self-Suction-LEMSAPI MED SPAFHN2026-02-06
16932503532928Multiple Band Ligator SetMicro-Tech (Nanjing) Co., Ltd.FHN2026-01-30
06923646508645Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508652Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508669Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508676Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508683Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508690Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508706Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508713Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508720Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508744Ligation DeviceLeo Medical Co., Ltd.FHN2026-01-04
06923646508638Ligation DeviceLeo Medical Co., Ltd.FHN2025-12-18
06923646508737Ligation DeviceLeo Medical Co., Ltd.FHN2025-12-18
00860006350277Snyder HemBandWILBUR HILL LLCFHN2025-09-04
00868852000414EZ Band Hemorrhoidal LigatorWILBUR HILL LLCFHN2025-09-04
00194613121907MSI Precision Specialty InstrumentsMed Saver, Inc.FHN2025-08-01
00190776401757MillenniumAvalign Technologies, Inc.FHN2025-06-12
00858276007410In-SightMicro-tech UsaFHN2025-03-03
00840183529307BR Surgical, LLCBR Surgical, LLCFHN2025-01-03