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

GMDN Terms#

Term, Definition table
TermDefinition
TonsillectomeA hand-held manual surgical instrument designed to remove tonsils during a toncillectomy. It can be designed as either a flexible loop for grasping and holding the tonsil or a metal frame which holds and guides a sliding knife blade (a guillotine). The loop type holds the tonsil so it may be surgically cut with a knife. The frame type has a variety of designs of manual cranks that operate the sliding knife blade which cuts off the tonsil. 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

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