FDA.reportPublic FDA data

Avalign

Primary DI
00190776228095
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM105-3111
Device description
Daniels Tonsillectome Blade,
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
KCATONSILLECTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCATonsillectomeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776228095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776228095001907762280951907762280950190776228095

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
00190776437329Millennium1-803EB2026-11-02
00190776437336Millennium1-80111EB2026-11-02
00190776437343Millennium1-750EB2026-11-02
00190776437350Millennium1-911172026-11-02
00190776437367Millennium1-BIO11042C2026-11-02
00190776437374Millennium1-SS937182026-11-02
00190776437381Millennium1-620030012026-11-02
00190776437398Millennium1-3104952026-11-02
00190776437404Millennium1-1852312026-11-02
00190776437411Millennium1-1851962026-11-02
00190776437428Millennium72-2358702042026-11-02
00190776437435Millennium72-2358702012026-11-02
00190776437442Millennium1-1103332026-11-02
00190776437459Millennium1-500135L2026-11-02
00190776437466Millennium1-2302142026-11-02
00190776437237Millennium1-121195EB2026-10-30
00190776437244Millennium1-018EB2026-10-30
00190776437251Millennium1-010EB2026-10-30
00190776437268Millennium1-7772EB2026-10-30
00190776437275Millennium1-7082EB2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190660000042Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000059Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000066Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000073Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000080Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
00190660000097Ambler SurgicalAMBLER SURGICAL CORP.KCA2021-01-04
M6334164410JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644110JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644120JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
M63341644130JEDMEDJEDMED INSTRUMENT COMPANYKCA2020-09-01
04038653180226AESCULAPAesculap AGKCA2020-06-17
04038653180233AESCULAPAesculap AGKCA2020-06-17
04038653180240AESCULAPAesculap AGKCA2020-04-23
04038653180257AESCULAPAesculap AGKCA2020-04-23
24026704507515PILLINGTELEFLEX INCORPORATEDKCA2018-09-15
24026704507522PILLINGTELEFLEX INCORPORATEDKCA2018-09-15
24026704507539PILLINGTELEFLEX INCORPORATEDKCA2018-09-15