FDA.reportPublic FDA data

Avalign

Primary DI
00190776055943
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM76-8117
Device description
Chest Tube Passers, curved shaft,
Published
2023-06-23
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
BWBFORCEPS, TUBE INTRODUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWBForceps, Tube IntroductionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776055943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776055943001907760559431907760559430190776055943

GMDN Terms#

Term, Definition table
TermDefinition
Airway tube forceps, reusableA hand-held instrument used for grasping a tube [e.g., a catheter or an endotracheal (ET) tube] for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways. Commonly known as a Magill's forceps, it typically has a scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will typically have grasping blades that have small ringed loops or S-shaped distal working ends. The blades are serrated to provide extra grip. It is typically used by emergency medical services (EMS). 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
05010058079922InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-06-19
05010058179929InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-06-19
05010058079939InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-05-21
05010058179936InstrapacROBINSON HEALTHCARE LIMITEDBWB2025-05-21
00888515023420BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
00888515023437BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
00888515023451BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.BWB2024-02-28
20653160369803CenturionCENTURION MEDICAL PRODUCTS CORPORATIONBWB2023-12-28
10653160369806CenturionCENTURION MEDICAL PRODUCTS CORPORATIONBWB2023-12-28
G58678TIF020Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G58678TIF030Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G58678TIF040Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95686120Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95692280Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95693270Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
G586E95693280Novo SurgicalNOVO SURGICAL, INC.BWB2023-12-18
07898506813551QuinelatoSchobell Industrial LtdaBWB2023-07-07
07898506849307QuinelatoSchobell Industrial LtdaBWB2023-07-07
05055382848769Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
05055382848783Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
05055382848806Eco MagillTIMESCO HEALTHCARE LIMITEDBWB2023-06-20
00840183504052BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183505042BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183505189BR Surgical, LLCBR Surgical, LLCBWB2023-04-06
00840183511715BR Surgical, LLCBR Surgical, LLCBWB2023-03-28
00840183519216BR Surgical, LLCBR Surgical, LLCBWB2023-03-28
07898506813568QuinelatoSchobell Industrial LtdaBWB2022-12-08
00842331185793Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-14
00842331167072Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-13
00842331167751Novo Surgical Inc. NOVO SURGICAL, INC.BWB2022-11-13