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
00190776436902Millennium1-5053602026-10-23
00190776436919Millennium1-3994896SS2026-10-23
00190776436926Millennium1-3110196SS2026-10-23
00190776436933Millennium1-3139696SS2026-10-23
00190776436940Millennium1-399481SS2026-10-23
00190776436957Millennium1-45382026-10-23
00190776436964Millennium72-321001IM2026-10-23
00190776436971Millennium72-321002IM2026-10-23
00190776436988Millennium72-321003IM2026-10-23
00190776436995Millennium1-3417302026-10-23
00190776437008Millennium72-1371112026-10-23
00190776437015Millennium1-MPR1049012026-10-23
00190776437022Millennium1-MPR1049022026-10-23
00190776437039Millennium92-F2710CT2026-10-23
00190776437046Millennium92-F2050T2026-10-23
00190776437053Millennium92-F2710T2026-10-23
00190776436827Millennium72-3130082OLY2026-10-22
00190776436834Millennium1-1211272026-10-22
00190776436841Millennium63-AOCOMES2026-10-22
00190776436858Millennium100-S03420NSR2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397166MillenniumAvalign Technologies, Inc.BWB2026-07-16
00840183531591BR Surgical, LLCBR Surgical, LLCBWB2026-07-16
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