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
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435530Millennium1-636012026-10-20
00190776435547Millennium72-5255540SL2026-10-20
00190776435554Millennium1-9356482026-10-20
00190776435561Millennium72-522056116202026-10-20
00190776435578Millennium1-225402L2026-10-20
00190776435585Millennium1-225402R2026-10-20
00190776435592Millennium1-6020222026-10-20
00190776435608Millennium1-6020172026-10-20
00190776436612Millenium85-630049412026-10-20
00190776436629Millenium85-110109462026-10-20
00190776436636Millenium85-520062822026-10-20
00190776436643Millenium85-520029442026-10-20
00190776436674Millenium85-420339012026-10-20
00190776436681Millenium85-520234622026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995294267V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00724995294274V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00724995294281V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00724995294298V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00724995294304V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00724995294311V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00724995294328V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00724995294335V. MuellerSTERIS Deutschland GmbHHDE2026-09-25
00198506092732ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506092749ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506092831ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
00198506093869ELMED INCORPORATEDELMED INCORPORATEDHDE2026-07-28
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