FDA.reportPublic FDA data

Avalign

Primary DI
00190776211929
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM59-2516
Device description
Buie Fistula 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
HDEHOOK, FIBROID, GYNECOLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDEHook, Fibroid, GynecologicalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776211929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776211929001907762119291907762119290190776211929

GMDN Terms#

Term, Definition table
TermDefinition
Rectal probeA hand-held manual surgical instrument designed for exploring the tissues and structures of the rectum during a gastroenterological/urological surgical 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
00190776397029Millennium85-230835662026-07-22
00190776403874Millennium85-760P211392026-07-22
00190776403881Millennium85-900117122026-07-22
00190776403904Millennium85-710186242026-07-22
00190776403911Millennium85-220085422026-07-22
00190776403928Millennium85-100042872026-07-22
00190776403935Millennium85-100042862026-07-22
00190776403942Millennium85-140182802026-07-22
00190776403959Millennium85-600028502026-07-22
00190776403966Millennium85-600028542026-07-22
00190776403973Millennium85-530183682026-07-22
00190776403980Millennium85-120155172026-07-22
00190776404000Millennium85-670334872026-07-22
00190776404017Millennium9-553950032026-07-22
00190776404024Millennium85-670335682026-07-22
00190776404031Millennium9-553950012026-07-22
00190776404048Millennium85-670335142026-07-22
00190776404055Millennium85-670335882026-07-22
00190776404062Millennium85-670335732026-07-22
00190776404079Millennium85-670335962026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091667ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-10
00190776419271MillenniumAvalign Technologies, Inc.HDE2026-04-14
00190776414337MillenniumAvalign Technologies, Inc.HDE2025-10-23
00198506086069ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-08
00198506072895ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-02
00198506072987ELMED INCORPORATEDELMED INCORPORATEDHDE2025-10-02
00198506085819ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-25
00198506085833ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-25
00198506085680ELMED INCORPORATEDELMED INCORPORATEDHDE2025-09-18
00198506083235ELMED INCORPORATEDELMED INCORPORATEDHDE2025-05-29
00198506081156ELMED INCORPORATEDELMED INCORPORATEDHDE2025-03-10
G586OB6301180Novo SurgicalNOVO SURGICAL, INC.HDE2023-12-18
G586OB96301210Novo SurgicalNOVO SURGICAL, INC.HDE2023-12-18
00842331193538Novo Surgical Inc. NOVO SURGICAL, INC.HDE2023-12-07
00842331193545Novo Surgical Inc. NOVO SURGICAL, INC.HDE2023-12-07
00840319748350Hayden MedicalHayden Medical, Inc.HDE2023-03-21
00840319748367Hayden MedicalHayden Medical, Inc.HDE2023-03-21
14026704792280PILLINGTELEFLEX INCORPORATEDHDE2022-12-08
54026704792288PILLINGTELEFLEX INCORPORATEDHDE2022-12-08
00842331131370Novo Surgical Inc. NOVO SURGICAL, INC.HDE2022-11-10
00842331131417Novo Surgical Inc. NOVO SURGICAL, INC.HDE2022-11-10
00840306807305Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HDE2022-11-07
00887482074831Symmetry BuieASPEN SURGICAL PRODUCTS, INC.HDE2022-08-24
00190776041717AvalignAvalign Technologies, Inc.HDE2021-11-03
00190776176884MillenniumAvalign Technologies, Inc.HDE2021-11-01
00190776176891MillenniumAvalign Technologies, Inc.HDE2021-11-01
00190660127190Ambler SurgicalAMBLER SURGICAL CORP.HDE2021-01-07
00190660127657Ambler SurgicalAMBLER SURGICAL CORP.HDE2021-01-07
00190660127664Ambler SurgicalAMBLER SURGICAL CORP.HDE2021-01-07
00190660213824Ambler Value LineAMBLER SURGICAL CORP.HDE2021-01-07